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
3457–3480 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 16, 1979
HUMAN CERULOPLASMIN
K791339 · DDB
Beckman Instruments, Inc.
Immunology · 31d
Cleared Aug 16, 1979
HUMAN ALPHA2 MACROGLOBULIN
K791340 · DEB
Beckman Instruments, Inc.
Immunology · 31d
Cleared Aug 16, 1979
HUMAN ALPHA, ACID GLYCOPROTEIN
K791341 · DEX
Beckman Instruments, Inc.
Immunology · 31d
Cleared Aug 03, 1979
ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN
K790710 · DDY
Kent Laboratories, Inc.
Immunology · 113d
Cleared Aug 03, 1979
ANTISERUM TO HUMAN C-REACTIVE PROTEINS
K790716 · DCN
Kent Laboratories, Inc.
Immunology · 113d
Cleared Aug 03, 1979
RADIOIMMUNOASSAY TEST SYSTEM
K791096 · JMG
Corning Medical & Scientific
Immunology · 52d
Cleared Jul 30, 1979
IIF-APCA TEST KIT
K790759 · DBJ
Medica Corp.
Immunology · 104d
Cleared Jul 24, 1979
CORNING PARAPROTEIN SCREENING
K790667 · CFF
Corning Medical & Scientific
Immunology · 109d
Cleared Jun 28, 1979
DIMENSIONALL ROTATOR
K790753 · JRQ
American Hospital Supply Corp.
Immunology · 72d
Cleared Jun 28, 1979
RF CONTROLS
K790986 · DMR
Wampole Laboratories
Immunology · 34d
Cleared May 25, 1979
TEST KIT, IIF-AMA
K790295 · DBM
Medica Corp.
Immunology · 105d
Cleared May 23, 1979
HELENA QUIPLATE SYSTEM
K790646 · JZQ
Helena Laboratories
Immunology · 54d
Cleared May 15, 1979
ASSAY REAGENTS, LSA 290
K790588 · JEW
Kallestad Laboratories, Inc.
Immunology · 49d
Cleared Apr 23, 1979
AUTOANTIBODY REAGENTS, AFT SYSTEM II
K790280 · DHN
Calbiochem-Behring Corp.
Immunology · 69d
Cleared Apr 23, 1979
I BRADYKININ & ANTI-BRADYKININ ANTISERUM
K790362
Cambridge Nuclear Corp.
Immunology · 60d
Cleared Apr 23, 1979
MEDICA II-F-ASMA TEST KIT
K790430 · DBE
Medica Corp.
Immunology · 52d
Cleared Apr 23, 1979
VENTRE/SEP FERRITIN RIA
K790447 · DBF
Ventrex Laboratories, Inc.
Immunology · 49d
Cleared Apr 23, 1979
NEIA-FERRITIN ENZYMEIMMUNASSAY KIT
K790490 · DBF
New England Immunology Assoc.
Immunology · 46d
Cleared Apr 12, 1979
CORDIA T
K790212 · GOL
Cordis Corp.
Immunology · 72d
Cleared Apr 12, 1979
ANTISERUM, HUMAN, IGA
K790703 · CZP
Kent Laboratories, Inc.
Immunology
Cleared Apr 12, 1979
ANTISERUM TO HUMAN IGG
K790704 · DEW
Kent Laboratories, Inc.
Immunology
Cleared Apr 12, 1979
ANTISERUM TO HUMAN IGM
K790705 · DAO
Kent Laboratories, Inc.
Immunology
Cleared Apr 04, 1979
RADIOASSAY, CONTROL SERUM I, II, III
K790298 · DGR
Kallestad Laboratories, Inc.
Immunology · 51d
Cleared Apr 04, 1979
A-GENT-HDL REAGENT
K790329 · LBR
Abbott Laboratories
Immunology · 47d