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
1345–1368 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 20, 1998
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
K981030 · MOB
The Binding Site, Ltd.
Immunology · 123d
Cleared Jul 10, 1998
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER...
K981698 · MOI
Chiron Corp.
Immunology · 57d
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