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
2281–2304 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 26, 1990
NOVA LITE(TM) ANA MK
K901595 · DHN
Inova Diagnostics, Inc.
Immunology · 21d
Cleared Apr 26, 1990
APOLIPOPROTEIN A-I (APO A-I)
K901675 · DEL
Sigma Chemical Co.
Immunology · 16d
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