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
2353–2376 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 13, 1989
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
K891680 · JJY
Bio-Rad
Immunology · 84d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-QUANTITATIVE
K892444 · DHR
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-SEMIQUANTITATIVE
K892445 · DHR
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Jun 02, 1989
ALATOP (TM) CATALOG # AKAL1
K892197 · DGC
Diagnostic Products Corp.
Immunology · 60d
Cleared Jun 02, 1989
ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)
K893036 · LRM
Amersham Corp.
Immunology · 39d
Cleared Jun 02, 1989
PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC
K893132 · DHB
Pharmacia, Inc.
Immunology · 38d
Cleared May 17, 1989
NOVA GEL(TM) JO-1
K892897 · LLL
Inova Diagnostics, Inc.
Immunology · 27d
Cleared May 09, 1989
PHADIATOP PAEDIATRIC RIA AND EIA
K891135 · DHB
Pharmacia, Inc.
Immunology · 67d
Cleared May 09, 1989
MONI-TROL(R)
K891929 · JJY
Baxter Healthcare Corp
Immunology · 42d
Cleared May 09, 1989
TECHNICON DPA-1 (TM) CRP METHOD
K892198 · DCK
Technicon Instruments Corp.
Immunology · 36d
Cleared May 09, 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · DBF
Amersham Corp.
Immunology · 33d
Cleared May 09, 1989
MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
K892421 · LJM
Lipogen, Inc.
Immunology · 29d
Cleared May 09, 1989
SPQ TM TEST SYSTEM II FOR CRP
K892526 · DCK
Atlantic Antibodies
Immunology · 28d
Cleared May 04, 1989
BEHRING NEPHELOMETER 100
K892223 · JZW
Behring Diagnostics, Inc.
Immunology · 31d
Cleared May 04, 1989
QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN
K892409 · DHB
Quidel Corp.
Immunology · 27d
Cleared Apr 21, 1989
V-TREND TARGET CRP TEST
K892231 · DCN
Texas Immunology, Inc.
Immunology · 17d
Cleared Apr 14, 1989
ANA-5 AUTOANTIBODY PROFILE KIT
K885224 · LKJ
Autoimmunity Diagnostics Corp.
Immunology · 115d
Cleared Apr 14, 1989
EZ COMPLEMENT C1
K891904 · DAC
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
QUIK-DOT C REACTIVE PROTEIN
K892119 · DCK
Ampcor, Inc.
Immunology · 14d
Cleared Apr 14, 1989
EZ COMPLEMENT C2
K892125 · CZW
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
EZ COMPLEMENT C3
K892127 · CZW
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
EZ COMPLEMENT C4
K892129 · DBI
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
C REACTIVE PROTEIN LIQUID
K892146 · DCK
Ampcor, Inc.
Immunology · 14d
Cleared Apr 12, 1989
TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
K891683 · CZN
Helena Laboratories
Immunology · 21d