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
1177–1200 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 14, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS...
K983875 · LTK
Ortho-Clinical Diagnostics, Inc.
Immunology · 193d
Cleared May 14, 1999
ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210,...
K991048 · DHB
Pharmacia & Upjohn Co.
Immunology · 45d
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