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
1177–1200 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 14, 1999
K-ASSAY CRP
K991224 · DCK
Kamiya Biomedical Co.
Immunology · 32d
Cleared May 13, 1999
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6
K991094 · JZO
Diagnostic Products Corp.
Immunology · 42d
Cleared May 13, 1999
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06
K991096 · JZO
Diagnostic Products Corp.
Immunology · 42d
Cleared May 11, 1999
ABBOTT ARCHITECT CEA
K990774 · DHX
Abbott Laboratories
Immunology · 63d
Cleared May 11, 1999
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
K991136 · JZG
Olympus America, Inc.
Immunology · 36d
Cleared May 11, 1999
K-ASSAY CRP CALIBRATOR SET
K991210 · DCK
Kamiya Biomedical Co.
Immunology · 32d
Cleared May 03, 1999
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
K990704 · DCK
Beckman Coulter, Inc.
Immunology · 60d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SM/RNP ELISA
K990624 · LKO
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SM ELISA
K990625 · LKP
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SS-B/LA ELISA
K990626 · LLL
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SS-A/RO ELISA
K990627 · LLL
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
K990796 · MOB
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SCL-70 ELISA
K990797 · LLL
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-JO-1 ELISA
K990798 · LLL
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Apr 21, 1999
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
K990915 · DHN
Stellar Bio Systems, Inc.
Immunology · 34d
Cleared Apr 21, 1999
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
K990916 · KTL
Stellar Bio Systems, Inc.
Immunology · 34d
Cleared Apr 16, 1999
REVISED C-REACTIVE PROTEIN CALIBRATOR
K990824 · JIT
Dade Behring, Inc.
Immunology · 35d
Cleared Apr 16, 1999
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
K990825 · DCN
Dade Behring, Inc.
Immunology · 35d
Cleared Apr 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
K990984 · JJX
Ortho-Clinical Diagnostics, Inc.
Immunology · 15d
Cleared Apr 07, 1999
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
K990587 · DHR
Bio-Rad
Immunology · 43d
Cleared Apr 06, 1999
IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
K990886 · DCK
Diagnostic Products Corp.
Immunology · 20d
Cleared Mar 26, 1999
GLIADIN IGG ELISA TEST SYSTEM
K990204 · MST
Zeus Scientific, Inc.
Immunology · 64d
Cleared Mar 26, 1999
GLIADIN IGA ELISA TEST SYSTEM
K990207 · MST
Zeus Scientific, Inc.
Immunology · 64d
Cleared Mar 25, 1999
IGG FLEX REAGENT CARTRIDGE
K990551 · CFQ
Dade Behring, Inc.
Immunology · 31d