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
3529–3552 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 27, 1978
KAPPA SERUM (FREE & BOUND) ANTI-HUMAN
K781028 · DFH
Icl Scientific
Immunology · 38d
Cleared Jul 27, 1978
RIA TSH IN HUMAN SERUM OR PLASMA
K781150 · JLW
Diagnostic Corp. of America
Immunology · 17d
Cleared Jul 27, 1978
ANTI-HUMAN LAMBDA SERUM
K781220 · DEH
Icl Scientific
Immunology · 10d
Cleared Jun 29, 1978
ACU-TEST IN-HOME PREGNANCY TEST
K781049 · JHJ
Williams, the J.B. Co., Inc.
Immunology · 7d
Cleared Jun 22, 1978
ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM
K780913 · DCF
Beckman Instruments, Inc.
Immunology · 17d
Cleared Jun 22, 1978
KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT
K780982 · DDR
Cis Radiopharmaceuticals, Inc.
Immunology · 8d
Cleared Jun 14, 1978
B-HCG-RIA
K780679 · JHI
Nuclear Medical Systems, Inc.
Immunology · 51d
Cleared Jun 14, 1978
THYMUNE-M
K780873 · DDC
Burroughs Wellcome Co.
Immunology · 15d
Cleared Jun 14, 1978
THYMUNE-T
K780874 · DDC
Burroughs Wellcome Co.
Immunology · 15d
Cleared Jun 13, 1978
TESTOSTERONE RADIOIMMUNOASSAY KIT 125I
K780792 · CDZ
The Upjohn Co.
Immunology · 29d
Cleared Jun 06, 1978
LAS-R HUMAN IGE TEST
K780753 · DGC
Hyland Therapeutic Div., Travenol...
Immunology · 29d
Cleared May 18, 1978
FOLATE REAGENT KIT, ARIA-II SYSTEM
K780557 · CGN
Bd Becton Dickinson Vacutainer...
Immunology · 43d
Cleared May 18, 1978
LAS-R HUMAN COMPLEMENT CLQ TEST
K780729 · DAK
Hyland Therapeutic Div., Travenol...
Immunology · 16d
Cleared Apr 28, 1978
AMINOGLYCOSIDE TEST SYSTEM
K772116 · DJB
Nichols Institute Diagnostics
Immunology · 172d
Cleared Apr 28, 1978
GENTAMICIN RIA KIT
K780516 · DJB
Antibodies, Inc.
Immunology · 29d
Cleared Apr 12, 1978
THEOPHYLLINE ASSAY TO THE CENTRIFICHEM
K780441 · LCY
Syva Co.
Immunology · 23d
Cleared Apr 12, 1978
THEOPHYLLINE ASSAY TO THE GEMSAEC
K780442 · LCY
Syva Co.
Immunology · 23d
Cleared Apr 10, 1978
NEIA-FERRITIN ENZYMEIMMUNOASSAY
K780490 · DBF
New England Immunology Assoc.
Immunology · 14d
Cleared Mar 27, 1978
IN VITRO THEOPHYLLINE RIA TEST
K772017 · KLS
Clinical Assays, Inc.
Immunology · 152d
Cleared Mar 22, 1978
LAS-R HUMAN C1 ESTERASE INHIBITOR TEST
K780335 · DBA
Hyland Therapeutic Div., Travenol...
Immunology · 22d
Cleared Mar 22, 1978
MIF PROCEDURE KIT
K780346 · JTS
Marion Laboratories, Inc.
Immunology · 21d
Cleared Mar 22, 1978
T3 UPTAKE TEST
K780361 · KHQ
Monobind
Immunology · 16d
Cleared Mar 22, 1978
COUNTER, RADIOASSAY, AUTO., MICROMEDIC
K780383 · JJJ
Micromedic Systems
Immunology · 13d
Cleared Mar 22, 1978
ANALYZER, 100, BICHROMATIC, ABBOTT
K780388 · JJE
Syva Co.
Immunology · 12d