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
3577–3600 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 20, 1978
GASTRIN RIA MODULE
K771953 · CGC
Inter Science Institute
Immunology · 95d
Cleared Jan 20, 1978
FIAX TEST FOR ANTI-RUBELLA ANTIBODY
K772219 · DHN
Idt, A Division of Whittaker M.A....
Immunology · 46d
Cleared Jan 20, 1978
AMINOGLYCOSIDE TEST SYSTEM
K780048 · DID
Nichols Institute Diagnostics
Immunology · 11d
Cleared Jan 12, 1978
KANAMYCIN RIA
K772038 · KJI
Monitor Science Corp.
Immunology · 76d
Cleared Jan 12, 1978
TESTOSTERONE RIA KIT (125I)
K772191 · CDZ
Diagnostic Products Corp.
Immunology · 48d
Cleared Jan 12, 1978
NEONATAL TSH RIA KIT (125I)
K772192 · JLW
Diagnostic Products Corp.
Immunology · 48d
Cleared Jan 12, 1978
T4 RIA KIT
K772330 · CDX
Bd Becton Dickinson Vacutainer...
Immunology · 22d
Cleared Jan 06, 1978
IMMO PHASE FT4 ASSAY
K772194 · CEC
Corning Medical & Scientific
Immunology · 39d
Cleared Jan 05, 1978
HEMAGGLUTINATION INHIBITION TEST
K772095 · DDR
Miles Laboratories, Inc.
Immunology · 59d
Cleared Jan 05, 1978
CERULOPLASMIN NEPHEL. ASSAY
K772255 · DDB
Kallestad Laboratories, Inc.
Immunology · 27d
Cleared Jan 05, 1978
RIANEN GENTAMICIN RIA KIT
K772425 · DJB
New England Nuclear
Immunology · 7d
Cleared Dec 22, 1977
SPINSEP-T3
K771854 · KHQ
Nuclear Diagnostics, Inc.
Immunology · 85d
Cleared Dec 22, 1977
EMIT CENTRIFICHEM THYROXINE ASSAY
K772170 · CDX
Syva Co.
Immunology · 31d
Cleared Dec 22, 1977
TRI-TAB-RIA
K772177 · CDP
Nuclear Medical Laboratories, Inc.
Immunology · 31d
Cleared Dec 22, 1977
FSH RIA KIT (125I)
K772188 · FSH
Diagnostic Products Corp.
Immunology · 27d
Cleared Dec 22, 1977
UNCONJUGATED ESTRIOL RIA KIT
K772215 · CGI
Amersham Corp.
Immunology · 20d
Cleared Dec 22, 1977
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K772245 · DAD
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY
K772246 · DEB
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K772247 · DBI
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
ALBUMIN NEPHELOMETRIC ASSAY
K772248
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K772249 · CEW
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY
K772250 · DEI
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
IMMUNOGLOBULIN A NEPHEL. ASSAY
K772251 · CZP
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
IMMUNOGLOBULIN G NEPHEL. ASSAY
K772252 · DEW
Kallestad Laboratories, Inc.
Immunology · 13d