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
3337–3360 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 26, 1981
AUTOMATED IMMUNOPRECIPITIN METHOD/ICG
K803272 · DFZ
Icl Scientific
Immunology · 28d
Cleared Jan 26, 1981
AUTOMATED IMMUNOPRECIPITIN METHOD/IGA
K803274 · CZP
Icl Scientific
Immunology · 28d
Cleared Jan 26, 1981
ANA-IFA TEST SYSTEM
K803276 · DHN
Immuno Concepts, Inc.
Immunology · 28d
Cleared Jan 05, 1981
RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
K802448 · DHR
Syn-Kit, Inc.
Immunology · 89d
Cleared Jan 05, 1981
TEST KIT FOR DETECTION OF ANTINUCLEAR
K802527 · DHN
Bartels & Stout, Inc.
Immunology · 82d
Cleared Jan 05, 1981
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
K802610 · DER
Hyland Therapeutic Div., Travenol...
Immunology · 76d
Cleared Dec 19, 1980
CYBREX CARBAMAZEPINE
K802902 · KLT
Abbott Laboratories
Immunology · 32d
Cleared Dec 18, 1980
RUBELLA ELISA REAGENTS RUBELLA IGG ANTI
K802102 · GOL
Calbiochem-Behring Corp.
Immunology · 106d
Cleared Dec 18, 1980
RHEUMATOID FACTOR TEST SYSTEMS
K802688 · DHR
Bd Becton Dickinson Vacutainer...
Immunology · 50d
Cleared Dec 11, 1980
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT
K802822 · JHO
Beckman Instruments, Inc.
Immunology · 31d
Cleared Dec 02, 1980
PHADEBAS RAST TEST
K802556 · DHB
Pharmacia, Inc.
Immunology · 47d
Cleared Dec 01, 1980
T/K (ATA/AMA) UNIVERSAL BIOPAK
K802308 · DBM
Bioware Products
Immunology · 69d
Cleared Nov 12, 1980
GESTE FOLLOW KIT DETERM. OF HPL
K802454 · JMF
Syn-Kit, Inc.
Immunology · 35d
Cleared Oct 31, 1980
GOAT ANTI-HUMAN IGM
K802177 · DFT
Protos Laboratories
Immunology · 52d
Cleared Oct 31, 1980
GOAT ANTI-HUMAN COMPLEMENT C4
K802196 · DBI
Protos Laboratories
Immunology · 51d
Cleared Oct 31, 1980
GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC
K802257 · DEW
Protos Laboratories
Immunology · 45d
Cleared Oct 31, 1980
ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
K802461 · LCW
Immunotech Corp.
Immunology · 23d
Cleared Oct 23, 1980
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY
K802066 · KLS
Immunotech Corp.
Immunology · 57d
Cleared Oct 23, 1980
ANTISERA TO HUMAN FREE KAPPA CHAINS
K802283 · DFH
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Oct 23, 1980
ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.
K802284 · CZQ
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Oct 23, 1980
ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE
K802404 · DCF
Ortho Diagnostics, Inc.
Immunology · 17d
Cleared Oct 10, 1980
ANTI-DS/N-DNA TEST KIT
K801960 · DBL
Immuno-Diagnostic Products, Inc.
Immunology · 52d
Cleared Oct 10, 1980
RF-II TEST KIT
K801961 · DHR
Immuno-Diagnostic Products, Inc.
Immunology · 52d
Cleared Oct 03, 1980
F/LS MCA APPLICATION SOFTWARE
K801456 · CFR
Instrumentation Laboratory CO
Immunology · 101d