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
2089–2112 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 22, 1992
BACTON(TM), AUTO-APO B REAGENT
K921862 · MSJ
Bacton Assay Systems, Inc.
Immunology · 69d
Cleared Jun 19, 1992
COBAS CORE FERRITIN EIA
K920829 · JMG
Roche Diagnostic Systems, Inc.
Immunology · 116d
Cleared Jun 19, 1992
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
K921183 · DBM
Shield Diagnostics, Ltd.
Immunology · 102d
Cleared Jun 16, 1992
IL TEST COMPLEMENT 3
K920007 · CZW
Instrumentation Laboratory CO
Immunology · 166d
Cleared Jun 16, 1992
IL TEST IMMUNOGLOBULIN A
K920014 · CZP
Instrumentation Laboratory CO
Immunology · 166d
Cleared Jun 04, 1992
SYNELISA CARDIOLIPIN ANTIBODIES
K921250 · MID
Elias U.S.A., Inc.
Immunology · 80d
Cleared May 28, 1992
SYN ELISA BETA 2 MICROGLOBULIN TEST KIT
K920132 · JZG
Elias U.S.A., Inc.
Immunology · 136d
Cleared May 28, 1992
IGG SUCLASS EIA
K921575 · DEW
Virotech Diagnostika
Immunology · 56d
Cleared May 22, 1992
THE THERATEST EL-ANA PROFILES
K914454 · LKJ
Theratest Laboratories, Inc.
Immunology · 228d
Cleared May 22, 1992
APOLIPOPROTEIN TEST SYSTEM
K921037 · MSJ
Baxter Diagnostics, Inc.
Immunology · 79d
Cleared May 11, 1992
DAB DETECTION KIT
K920600 · DEY
Ventana Medical Systems, Inc.
Immunology · 90d
Cleared May 08, 1992
AEC DETECTION KIT
K920566 · DEY
Ventana Medical Systems, Inc.
Immunology · 91d
Cleared May 01, 1992
AUTOSTAT(TM) ANTI-DSNA
K913342 · LKJ
Cogent Diagnotics , Ltd.
Immunology · 280d
Cleared Apr 08, 1992
SYNELISA TMAB
K915133 · JZO
Elias U.S.A., Inc.
Immunology · 147d
Cleared Apr 08, 1992
SYNELISA TGAB
K915134 · JZO
Elias U.S.A., Inc.
Immunology · 147d
Cleared Apr 08, 1992
SYNELISA TGAB/TMAB
K915135 · JZO
Elias U.S.A., Inc.
Immunology · 147d
Cleared Apr 08, 1992
ACS TOTAL IGE IMMUNOASSAY
K920372 · DGC
Ciba Corning Diagnostics Corp.
Immunology · 71d
Cleared Apr 07, 1992
HEMAGEN ENA [JO-1] KIT (EIA METHOD)
K915420 · LLL
Hemagen Diagnostics, Inc.
Immunology · 127d
Cleared Apr 07, 1992
VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
K920952 · DBF
Vitek Systems, Inc.
Immunology · 41d
Cleared Mar 30, 1992
MYOGLOBIN RIA TEST KIT
K915233 · DDR
Pro Diagnostics, Inc.
Immunology · 129d
Cleared Mar 30, 1992
KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT
K915428 · JZO
Kronus
Immunology · 119d
Cleared Mar 30, 1992
KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT
K915429 · JZO
Kronus
Immunology · 119d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST [SS-A (RO)]
K920383 · LLL
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANIT-ENA ANTIBODY TEST [SS-B (LA)]
K920384 · LLL
Immco Diagnostics, Inc.
Immunology · 60d