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
2089–2112 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 14, 1992
INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST
K922297 · KTN
Ampcor, Inc.
Immunology · 60d
Cleared Jun 23, 1992
BACTON(TM), AUTO-APO A-1 REAGENT
K921795 · MSJ
Bacton Assay Systems, Inc.
Immunology · 74d
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