Search FDA 510(k) Clearance Records

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

92 results for "Kallestad Laboratories, Inc."
25–48 of 92
Search insights Median review: 28d Cleared: 100% Top manufacturer: Kallestad Laboratories, Inc. Lead specialty: Immunology
Cleared Dec 15, 1982
ALLERCOAT ALLERGEN DISCS
K823470 · DHB
Kallestad Laboratories, Inc.
Immunology · 23d
Cleared Dec 15, 1982
ALLERCOAT POSITIVE CONTROL SERUM
K823403 · DGC
Kallestad Laboratories, Inc.
Immunology · 30d
Cleared Nov 16, 1982
QUANTIMETRIC 2 CERULOPLASMIN ASSAY
K823107 · DDB
Kallestad Laboratories, Inc.
Immunology · 26d
Cleared Oct 22, 1982
RAST ALLERCOAT ALLERGEN DISCS
K822613 · DGC
Kallestad Laboratories, Inc.
Immunology · 53d
Cleared Aug 16, 1982
TOTAL IGE DISCS
K822206 · DGC
Kallestad Laboratories, Inc.
Chemistry · 21d
Cleared Aug 03, 1982
IGE/THE OPHYLLINE CONTROL SERUM I,II,III
K822133 · JJY
Kallestad Laboratories, Inc.
Chemistry · 14d
Cleared Jul 22, 1982
QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.
K821984 · DCK
Kallestad Laboratories, Inc.
Immunology · 16d
Cleared Jul 06, 1982
QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.
K821862 · LCA
Kallestad Laboratories, Inc.
Chemistry · 12d
Cleared Apr 08, 1982
MARK 500 SYSTEM
K812416
Kallestad Laboratories, Inc.
Obstetrics & Gynecology · 227d
Cleared Apr 06, 1982
KALLESTAD RAST REAGENTS
K820029 · DHB
Kallestad Laboratories, Inc.
Immunology · 91d
Cleared Jan 18, 1982
QUANTAFLUOR FLUORESCENT TEST REAGENTS
K813592 · DHN
Kallestad Laboratories, Inc.
Immunology · 21d
Cleared Dec 02, 1981
QUANTIMETRIC 2 TEST KIT
K813242 · KEW
Kallestad Laboratories, Inc.
Immunology · 15d
Cleared Nov 10, 1981
IMMUNO-CELL IMMUNO-SEP KIT
K812411 · JCF
Kallestad Laboratories, Inc.
Hematology · 81d
Cleared Oct 02, 1981
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO
K812611 · CDP
Kallestad Laboratories, Inc.
Chemistry · 17d
Cleared Sep 14, 1981
KALLESTAD 125I ANTISERUM TO HUMAN IGE
K812414 · DHB
Kallestad Laboratories, Inc.
Chemistry · 24d
Cleared Sep 09, 1981
KALLESTAD ANTISERA TO TOBRAMYCIN
K812415 · KLB
Kallestad Laboratories, Inc.
Microbiology · 9d
Cleared Sep 01, 1981
KAPPA & LAMBDA BENCE JONES CONTROLS
K812327 · CZQ
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Aug 03, 1981
KALLESTAD ANTISERA TO GENTAMICIN
K812050 · DJI
Kallestad Laboratories, Inc.
Toxicology · 13d
Cleared Jul 16, 1981
KALLESTAD'S ENDOPLATE FACTOR B TEST
K811740 · JZH
Kallestad Laboratories, Inc.
Immunology · 27d
Cleared Jul 10, 1981
KALLESTAD QUANTICOAT 125 DIGOXIN
K811776 · DPO
Kallestad Laboratories, Inc.
Toxicology · 17d
Cleared Jul 10, 1981
KALLESTAD ANTISERA TO PHENYTOIN
K811775 · DLP
Kallestad Laboratories, Inc.
Toxicology · 17d
Cleared Jun 25, 1981
QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.
K811617 · DCK
Kallestad Laboratories, Inc.
Immunology · 17d
Cleared Jun 24, 1981
KALLESTAD QUANTITOPE LOW LEVEL IGE REAG
K811545 · DGC
Kallestad Laboratories, Inc.
Chemistry · 23d
Cleared Jun 24, 1981
KALLESTAD R QUANTIPLATE ALT. PATHWAY T.
K811445 · DHL
Kallestad Laboratories, Inc.
Immunology · 33d