FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×
3,792 results
2329–2352 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Jun 16, 1989
BECKMAN EPSILON(TM) IGE REAGENT KIT
K893125 · DGO
Beckman Instruments, Inc.
Immunology · 52d
Cleared Jun 16, 1989
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
K893737 · KTN
Quidel Corp.
Immunology · 30d