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
1345–1368 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 07, 1998
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY
K981559 · JZO
Pharmacia & Upjohn Co.
Immunology · 67d
Cleared Jul 07, 1998
ACS:CENTAUR AFP
K981592 · LOQ
Chiron Diagnostics Corp.
Immunology · 64d
Cleared Jul 07, 1998
UNICAP THYROID PEROXIDASE IGG
K981930 · JZO
Pharmacia & Upjohn Co.
Immunology · 67d
Cleared Jun 29, 1998
ELECSYS CEA ON THE ELECSYS 1010
K980887 · DHX
Boehringer Mannheim Corp.
Immunology · 112d
Cleared Jun 29, 1998
QUANTECH MYOGLOBIN ASSAY
K981536 · MVE
Hellen Professional Services
Immunology · 61d
Cleared Jun 19, 1998
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
K981328 · MOB
Inova Diagnostics, Inc.
Immunology · 67d
Cleared Jun 19, 1998
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
K981330 · MOB
Inova Diagnostics, Inc.
Immunology · 67d
Cleared Jun 15, 1998
SERAQUEST ANTI-SM
K980540 · LKP
Quest Intl., Inc.
Immunology · 123d
Cleared Jun 15, 1998
SERAQUEST ANTI-SSB
K980639 · LLL
Quest Intl., Inc.
Immunology · 116d
Cleared Jun 15, 1998
COLOR-SLIDE RF
K981496 · DHR
Seradyn, Inc.
Immunology · 49d
Cleared Jun 12, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K981638 · DCK
Beckman Coulter, Inc.
Immunology · 35d
Cleared Jun 05, 1998
QUANTA LITE RIBOSOME P ELISA
K981237 · MQA
Inova Diagnostics, Inc.
Immunology · 63d
Cleared Jun 02, 1998
ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
K981014 · MID
Zeus Scientific, Inc.
Immunology · 76d
Cleared Jun 02, 1998
ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
K981021 · MID
Zeus Scientific, Inc.
Immunology · 75d
Cleared May 28, 1998
AIA-PACK MYOGLOBIN ASSAY
K981012 · DDR
Tosoh Medics, Inc.
Immunology · 71d
Cleared May 18, 1998
ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
K981020 · MID
Zeus Scientific, Inc.
Immunology · 60d
Cleared May 12, 1998
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
K980337 · LJM
Helix Diagnostics, Inc.
Immunology · 104d
Cleared May 12, 1998
SERAQUEST ANTI-SSA
K980810 · LJM
Quest Intl., Inc.
Immunology · 70d
Cleared May 12, 1998
SERAQUEST ANTI-SM/RNP
K980811 · LKP
Quest Intl., Inc.
Immunology · 70d
Cleared May 01, 1998
IMMULITE ANTI-TG AB
K980206 · JZO
Diagnostic Products Corp.
Immunology · 101d
Cleared May 01, 1998
ELECSYS AFP
K981282 · LOJ
Roche Diagnostics GmbH
Immunology · 23d
Cleared May 01, 1998
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
K981354 · LOJ
Beckman Instruments, Inc.
Immunology · 17d
Cleared Apr 27, 1998
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · DDR
Dade Behring, Inc.
Immunology · 32d
Cleared Apr 24, 1998
SERAQUEST ANTI-DSDNA
K980391 · LRM
Quest Intl., Inc.
Immunology · 81d