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
1369–1392 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 23, 1998
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K980376 · LTJ
Bayer Corp.
Immunology · 83d
Cleared Apr 23, 1998
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
K980759 · LLL
Diamedix Corp.
Immunology · 55d
Cleared Apr 21, 1998
IMMULITE 2000 3RD GENERATION PSA
K974842 · LTJ
Diagnostic Products Corp.
Immunology · 118d
Cleared Apr 21, 1998
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
K980855 · DHX
Dpc Cirrus
Immunology · 47d
Cleared Apr 15, 1998
BARD BTA TRAK TEST
K971402 · MMW
Bard Diagnostic Sciences,Inc.
Immunology · 365d
Cleared Apr 03, 1998
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
K980716 · LTJ
Nichols Institute Diagnostics
Immunology · 86d
Cleared Apr 02, 1998
NOVA LITE ENDOMYSIAL
K980312 · DBL
Inova Diagnostics, Inc.
Immunology · 65d
Cleared Mar 25, 1998
ELECSYS CA 125II ON THE ELECSYS 1010
K980240 · LTK
Boehringer Mannheim Corp.
Immunology · 61d
Cleared Mar 24, 1998
QUANTA LITE B2 GPI SCREEN
K980230 · MSV
Inova Diagnostics, Inc.
Immunology · 61d
Cleared Mar 18, 1998
ELECSYS CA 125 II
K972162 · LTK
Boehringer Mannheim Corp.
Immunology · 282d
Cleared Mar 17, 1998
IMMUSTRIP HAMA IGG
K972873 · DAK
Immunomedics, Inc.
Immunology · 225d
Cleared Mar 06, 1998
DIAMEDIX IS-RF TEST SYSTEM
K974889 · DHR
Diamedix Corp.
Immunology · 66d
Cleared Mar 06, 1998
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
K980190 · MOI
Chiron Corp.
Immunology · 45d
Cleared Mar 04, 1998
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE...
K972591 · JKM
Morax
Immunology · 236d
Cleared Mar 03, 1998
IS-DSDNA TEST SYSTEM
K974694 · LRM
Diamedix Corp.
Immunology · 77d
Cleared Feb 24, 1998
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K972145 · DHN
Immuno Concepts, Inc.
Immunology · 263d
Cleared Feb 20, 1998
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974816 · LTJ
Beckman Instruments, Inc.
Immunology · 59d
Cleared Feb 18, 1998
RAPET CRP
K974429 · DCN
Stanbio Laboratory
Immunology · 86d
Cleared Feb 17, 1998
WIELISA MPO ANCA TEST SYSTEM
K974166 · MOB
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA PR-3 ANCA TEST SYSTEM
K974167 · MOB
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA ANTI-GBM TEST SYSTEM
K974169 · DBL
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
RAPET RF
K974370 · DHR
Stanbio Laboratory
Immunology · 89d
Cleared Feb 17, 1998
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
K974505 · DBF
Alfa Biotech (Uk) , Ltd.
Immunology · 78d
Cleared Feb 17, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
K974564 · DEB
Beckman Instruments, Inc.
Immunology · 74d