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
1321–1344 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 28, 1998
COBAS INTEGRA REAGENT CASSETTES
K982382 · CFN
Roche Diagnostic Systems, Inc.
Immunology · 82d
Cleared Sep 24, 1998
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205,...
K981985 · DHX
Beckman Coulter, Inc.
Immunology · 111d
Cleared Sep 24, 1998
ELECSYS MYOGLOBIN STAT ASSAY
K983176 · DDR
Boehringer Mannheim Corp.
Immunology · 14d
Cleared Sep 18, 1998
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
K981297 · LTK
Diagnostic Products Corp.
Immunology · 163d
Cleared Sep 17, 1998
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K982121 · DBM
Trace Scientific , Ltd.
Immunology · 93d
Cleared Sep 15, 1998
ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48,...
K982343 · DHB
Pharmacia & Upjohn Co.
Immunology · 71d
Cleared Sep 04, 1998
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
K982023 · DAS
Inova Diagnostics, Inc.
Immunology · 87d
Cleared Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG
K981644 · MST
The Binding Site, Ltd.
Immunology · 118d
Cleared Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
K981929 · MST
The Binding Site, Ltd.
Immunology · 118d
Cleared Aug 27, 1998
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA
K982366 · MVM
Inova Diagnostics, Inc.
Immunology · 51d
Cleared Aug 18, 1998
ROCHE CRP T CONTROL N
K982087 · DCK
Roche Diagnostic Systems, Inc.
Immunology · 64d
Cleared Aug 13, 1998
EL-ANA PROFILES: EL-ENA/4
K982150 · LLL
Theratest Laboratories, Inc.
Immunology · 56d
Cleared Aug 13, 1998
EL-ANA PROFILES: EL-ENA/5
K982622 · LLL
Theratest Laboratories, Inc.
Immunology · 56d
Cleared Aug 12, 1998
ACS:CENTAUR CEA
K981478 · DHX
Chiron Diagnostics Corp.
Immunology · 110d
Cleared Aug 12, 1998
ACS:CENTAUR PSA2 IMMUNOASSAY
K981839 · LTJ
Chiron Diagnostics Corp.
Immunology · 78d
Cleared Aug 12, 1998
TUMOR MARKER CONTROL
K982473 · JJY
Diagnostic Products Corp.
Immunology · 27d
Cleared Aug 12, 1998
IMMULITE PSA CONTROL MODULE, MODEL LPSCM
K982637 · JJY
Diagnostic Products Corp.
Immunology · 14d
Cleared Aug 03, 1998
ACTIVE PSA ELISA (DSL-10-9700)
K973243 · LTJ
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Aug 03, 1998
ACTIVE PSA IRMA (DSL-9700)
K973244 · LTJ
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Jul 29, 1998
QUIDEL CH50 EQ EIA
K974111 · DAE
Quidel Corp.
Immunology · 271d
Cleared Jul 29, 1998
QUANTA LITE TPO ELISA
K981857 · LLL
Inova Diagnostics, Inc.
Immunology · 63d
Cleared Jul 22, 1998
WIELISA ANCA SCREENING KIT TEST SYSTEM
K981748 · MOB
Wieslab AB
Immunology · 65d
Cleared Jul 22, 1998
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
K981750 · MOB
Wieslab AB
Immunology · 65d
Cleared Jul 20, 1998
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
K981029 · MOB
The Binding Site, Ltd.
Immunology · 123d