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
3433–3456 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 30, 1979
ANTI NUCLEAR ANTIBODY TEST
K791995 · DHN
Meda Stat Diagnostics, Inc.
Immunology · 27d
Cleared Oct 30, 1979
PREGTELL I
K792027 · JHJ
Central Biological Co.
Immunology · 21d
Cleared Oct 17, 1979
ANTI-HUMAN SERUM
K791282 · DGQ
Diagnostica, Inc.
Immunology · 99d
Cleared Oct 17, 1979
ANTI-HUMAN GLOBULINS
K791285 · DEW
Diagnostica, Inc.
Immunology · 99d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGA
K791401 · CZP
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGM
K791402 · DFT
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGG
K791403 · DEW
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
LANCER L-INA ANTI-C3
K791404 · CZW
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL
K791749 · DAA
Clinical Sciences, Inc.
Immunology · 37d
Cleared Oct 17, 1979
ANTISERUM TO HUMAN IMMUNOGLOBULINS
K791824 · DEW
Icl Scientific
Immunology · 33d
Cleared Sep 24, 1979
ANTI-NUCLEAR ANTIBODY TEST
K791493 · DHN
Meloy Laboratories, Inc.
Immunology · 53d
Cleared Sep 24, 1979
GOAT ANTI-HUMAN C-REACTIVE PROTEIN
K791560 · DCK
Protos Laboratories
Immunology · 38d
Cleared Sep 17, 1979
CODE QAS 103 ANTI-DNA CONTROLS
K791354 · KTL
Amersham Corp.
Immunology · 61d
Cleared Sep 17, 1979
HUMAN, C-REACTIVE PROTEIN (CRP)
K791650 · DCK
Beckman Instruments, Inc.
Immunology · 27d
Cleared Sep 12, 1979
ANTISERUM TO RABBIT IGG H & L CHAIN
K790706 · DFH
Kent Laboratories, Inc.
Immunology · 153d
Cleared Sep 04, 1979
ANTISERUM, HUMAN, IGG H & L CHAIN
K790702 · DEW
Kent Laboratories, Inc.
Immunology · 145d
Cleared Sep 04, 1979
ANTISERA TO HUMAN FRAGMENT
K790711 · DFK
Kent Laboratories, Inc.
Immunology · 145d
Cleared Sep 04, 1979
ANTISERUM TO HUMAN HEMOPEXIN
K790713 · CZX
Kent Laboratories, Inc.
Immunology · 145d
Cleared Sep 04, 1979
GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN
K791605 · DEM
Protos Laboratories
Immunology · 15d
Cleared Aug 22, 1979
ANTISERUM TO HUMAN IG G FC FRAGMENTS
K790708 · DAS
Kent Laboratories, Inc.
Immunology · 132d
Cleared Aug 16, 1979
ANTISERUM TO RABBIT IMMUNOGLOBULIN
K790709 · DFZ
Kent Laboratories, Inc.
Immunology · 126d
Cleared Aug 16, 1979
ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI
K790712 · DDB
Kent Laboratories, Inc.
Immunology · 126d
Cleared Aug 16, 1979
ANTISERUM TO HUMAN CERULOPLASMIN
K790714 · DDB
Kent Laboratories, Inc.
Immunology · 126d
Cleared Aug 16, 1979
ANTISERA TO RABBIT IMMUNOGLOBULIN
K790720 · DFZ
Kent Laboratories, Inc.
Immunology · 126d