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

Filters: Immunology ×
3,794 results
2329–2352 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 17, 1989
LAN.0800Q/2800Q
K895872 · DBF
Amersham Corp.
Immunology · 13d
Cleared Oct 06, 1989
ORTHO *APO A-1 ELISA TEST SYSTEM
K895160 · DEL
Medical Marketing Consultants, Inc.
Immunology · 44d
Cleared Oct 04, 1989
ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST
K895339 · LLL
Immco Diagnostics, Inc.
Immunology · 34d
Cleared Sep 28, 1989
MILENIA(TM) TOTAL IGE (MKIE1,5)
K895004 · DGC
Diagnostic Products Corp.
Immunology · 51d
Cleared Sep 27, 1989
ORTHO APO B ELISA TEST SYSTEM
K895277 · MSJ
Medical Marketing Consultants, Inc.
Immunology · 35d
Cleared Sep 21, 1989
ANA ANTISERA CONTROL KIT
K894659 · DHN
Lipogen, Inc.
Immunology · 59d
Cleared Sep 21, 1989
PROGENE IGE BEAD EIA
K895294 · DGC
Progene Corp.
Immunology · 27d
Cleared Sep 21, 1989
QM300 CERULOPLASMIN ANTIBODY PACK
K895377 · DDB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 22d
Cleared Sep 13, 1989
IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST
K894975 · KTN
General Biometrics, Inc.
Immunology · 37d
Cleared Aug 24, 1989
ANTI-SM MICROASSAY
K894894 · LJM
Diamedix Corp.
Immunology · 23d
Cleared Aug 21, 1989
MONODEX
K894793 · KTN
Cenogenics Corp.
Immunology · 24d
Cleared Aug 10, 1989
SCANLISA HUMAN CRP ELISA KIT
K894573 · DCK
Immuntech A/S
Immunology · 20d
Cleared Aug 10, 1989
TECHNICON DPA-1 SYSTEM RF METHOD
K894574 · DHR
Technicon Instruments Corp.
Immunology · 20d
Cleared Aug 04, 1989
QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
K894538 · DBN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 15d
Cleared Aug 02, 1989
SERATEST ENA [SCL-70] KIT
K894411 · LKJ
Hemagen Diagnostics, Inc.
Immunology · 16d
Cleared Aug 01, 1989
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM
K894252 · JJY
Bio-Rad
Immunology · 42d
Cleared Jul 28, 1989
QUIDEL FOOD ALLERGEN SCREEN
K894253 · DHB
Quidel Corp.
Immunology · 38d
Cleared Jul 25, 1989
ANTI-THYROGLOBULIN TEST KIT
K894203 · JZO
Kronus
Immunology · 36d
Cleared Jul 25, 1989
MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
K894364 · JZO
Kronus
Immunology · 11d
Cleared Jul 14, 1989
QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
K893896 · LKJ
Biostar Medical Products, Inc.
Immunology · 45d
Cleared Jul 14, 1989
PHARMACIA CAP SYSTEM IGE RIA AND FEIA
K893951 · DGC
Pharmacia, Inc.
Immunology · 43d
Cleared Jul 14, 1989
QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
K894039 · DGO
Quidel Corp.
Immunology · 38d
Cleared Jun 23, 1989
SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
K893897 · LKJ
Biostar Medical Products, Inc.
Immunology · 24d
Cleared Jun 21, 1989
BACTON TM, BASIC TM, APO B REAGENT
K893884 · MSJ
Catachem, Inc.
Immunology · 22d