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Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

58 results for "Kallestad Diag, A Div. of Erbamont, Inc."
1–24 of 58
Search insights Median review: 37d Cleared: 100% Top manufacturer: Kallestad Diag, A Div. of Erbamont, Inc. Lead specialty: Immunology
Cleared Jun 17, 1991
QM300 CONTROL G PACK
K910887 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
K910886 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
QM300 CALIBRATOR G PACK
K910885 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jan 14, 1991
CHLAMYDIA SYSTEM SOFTWARE (CSS)
K904725 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 89d
Cleared Jul 26, 1990
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
K902253 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 66d
Cleared Jun 21, 1990
MODIFIED QM300 RHEUMATOID FACTOR TEST
K902462 · DHR
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 17d
Cleared Apr 03, 1990
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
K900010 · JFT
Kallestad Diag, A Div. of Erbamont, Inc.
Toxicology · 91d
Cleared Mar 29, 1990
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
K900009 · KLS
Kallestad Diag, A Div. of Erbamont, Inc.
Toxicology · 86d
Cleared Mar 29, 1990
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · KLI
Kallestad Diag, A Div. of Erbamont, Inc.
Chemistry · 97d
Cleared Mar 23, 1990
PLATELIA TOXO IGG KIT
K894947 · LGO
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 232d
Cleared Mar 15, 1990
PLATELIA TOXO IGM KIT
K894948 · LGD
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 224d
Cleared Jan 22, 1990
ALLERCOAT MICROPLATE SYSTEM
K900028 · JJQ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Dec 21, 1989
PLATELIA RUBELLA IGG KIT
K894946 · LFX
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 140d
Cleared Dec 01, 1989
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
K896483 · DEB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 18d
Cleared Nov 06, 1989
MODIFIED QM300 ALBUMIN ANTIBODY PACK
K896059 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Oct 31, 1989
LP 400 MICROPLATE READER
K894859 · JJQ
Kallestad Diag, A Div. of Erbamont, Inc.
Chemistry · 92d
Cleared Sep 21, 1989
QM300 CERULOPLASMIN ANTIBODY PACK
K895377 · DDB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 22d
Cleared Aug 04, 1989
QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
K894538 · DBN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 15d
Cleared Dec 20, 1988
QM300 PCR ANTIBODY PACK
K885001 · DCN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Nov 30, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
K884517 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 34d
Cleared Nov 04, 1988
QM300 CONTROL E
K883537 · DHB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 78d
Cleared Oct 19, 1988
QM300 APOLIPOPROTEIN B ANTIBODY PACK
K883714 · MSJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 50d
Cleared Oct 19, 1988
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
K883713 · MSJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 50d
Cleared Sep 22, 1988
QM300 CONTROL F PACK
K883712 · DFC
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 23d