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
2281–2304 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 12, 1990
QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD
K901453 · DFT
Isolab, Inc.
Immunology · 16d
Cleared Apr 02, 1990
LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
K901075 · DBF
London Diagnostics, Inc.
Immunology · 25d
Cleared Apr 02, 1990
BETA-2 MICROGLOBULIN EIA
K901333 · JZG
Serex, Inc.
Immunology · 13d
Cleared Mar 23, 1990
REAADS ANTI-SM TEST KIT
K901230 · LLL
Biosearch Medical Products, Inc.
Immunology · 9d
Cleared Mar 19, 1990
ANTI-RNP MICROASSAY
K901073 · LLL
Diamedix Corp.
Immunology · 11d
Cleared Mar 02, 1990
APOLIPOPROTEIN B (APO B)
K900124 · DEL
Sigma Chemical Co.
Immunology · 52d
Cleared Feb 27, 1990
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
K900422 · CZP
Helena Laboratories
Immunology · 28d
Cleared Feb 26, 1990
AIA-PACK BMG
K900440 · JZG
Tosoh Medics, Inc.
Immunology · 28d
Cleared Feb 26, 1990
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
K900625 · KTN
Armkel, LLC
Immunology · 18d
Cleared Feb 23, 1990
SERATEST ENA [SSA] KIT
K900617 · LLL
Hemagen Diagnostics, Inc.
Immunology · 15d
Cleared Feb 21, 1990
3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
K900108 · DGC
3M Company
Immunology · 43d
Cleared Feb 21, 1990
3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8
K900244 · DGC
3M Company
Immunology · 35d
Cleared Feb 05, 1990
PHARMACIA B2 MICRO EIA
K900449 · JZG
Pharmacia, Inc.
Immunology · 6d
Cleared Feb 02, 1990
ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY
K900241 · LLL
Diamedix Corp.
Immunology · 16d
Cleared Jan 26, 1990
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
K896926 · KTN
Quidel Corp.
Immunology · 46d
Cleared Jan 24, 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2
K900072 · LJM
General Biometrics, Inc.
Immunology · 19d
Cleared Jan 22, 1990
PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA
K894190 · DHB
Pharmacia, Inc.
Immunology · 220d
Cleared Jan 22, 1990
ALLERCOAT MICROPLATE SYSTEM
K900028 · JJQ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Jan 22, 1990
TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT
K900167 · DCF
Behring Diagnostics, Inc.
Immunology · 10d
Cleared Jan 18, 1990
LD-1
K900107 · DET
Boehringer Mannheim Corp.
Immunology · 9d
Cleared Jan 10, 1990
ENZYMUN TEST R IGE
K896902 · DHB
Boehringer Mannheim Corp.
Immunology · 33d
Cleared Jan 10, 1990
3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8)
K897145 · DHB
3M Company
Immunology · 14d
Cleared Jan 02, 1990
ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
K897025 · DHN
Zeus Scientific, Inc.
Immunology · 14d
Cleared Dec 18, 1989
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K896852 · DHB
Ventrex Laboratories, Inc.
Immunology · 13d