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
3097–3120 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 22, 1983
B HCG-CHECK
K831468 · JHJ
Diagnostic Technology, Inc.
Immunology · 47d
Cleared Jun 22, 1983
FIAX IGA TEST KIT
K831607 · CZN
Intl. Diagnostic Technology
Immunology · 35d
Cleared Jun 22, 1983
FIAX IGM TEST KIT
K831608 · DFT
Intl. Diagnostic Technology
Immunology · 35d
Cleared Jun 17, 1983
GONORRHEA TRANSETTE 1 & 3
K831579 · JTW
Spectrum Diagnostic, Inc.
Immunology · 31d
Cleared Jun 17, 1983
FIAX IGG TEST KIT
K831609 · DGK
Intl. Diagnostic Technology
Immunology · 30d
Cleared Jun 16, 1983
ASO-CHECK
K831464 · GTQ
Diagnostic Technology, Inc.
Immunology · 41d
Cleared Jun 16, 1983
ALBUMIN REAGENT (BCG
K831585 · CIX
Reagents Applications, Inc.
Immunology · 30d
Cleared Jun 10, 1983
RADIAL IMMUNODIFFUSION PLATES
K830911 · DDG
Biocell Laboratories, Inc.
Immunology · 81d
Cleared Jun 08, 1983
LEGIONELLA DFA KIT I
K830820 · LHL
Bionetic Laboratory Products
Immunology · 85d
Cleared Jun 08, 1983
AMEBIASIS BIO-ENZABEAD SCREEN KIT
K831133 · KHW
Bionetic Laboratory Products
Immunology · 62d
Cleared Jun 08, 1983
NEO-PREGNOSTICON DUOCLON TUBE TEST
K831339 · JHJ
Organon, Inc.
Immunology · 44d
Cleared Jun 08, 1983
ANA-CHECK
K831463 · LKJ
Diagnostic Technology, Inc.
Immunology · 33d
Cleared Jun 08, 1983
CRP-CHECK
K831465 · DCN
Diagnostic Technology, Inc.
Immunology · 33d
Cleared Jun 08, 1983
RA-CHECK
K831467 · DHR
Diagnostic Technology, Inc.
Immunology · 33d
Cleared Jun 08, 1983
NEIN ALLERGEN DISC IN VAST VENTREX TEST
K831554 · DHB
Ventrex Laboratories, Inc.
Immunology · 26d
Cleared Jun 02, 1983
ARIA II I-HCG
K830997 · JHI
Bd Becton Dickinson Vacutainer...
Immunology · 65d
Cleared Jun 02, 1983
DUOCLON SLIDE TEST
K831109 · JHI
Organon, Inc.
Immunology · 58d
Cleared Jun 02, 1983
EMIT QST GENTAMICIN ASSAY
K831304 · LCD
Syva Co.
Immunology · 42d
Cleared Jun 02, 1983
ALLERCOAT ALLERGEN DISCS
K831326 · DGC
Kallestad Laboratories, Inc.
Immunology · 38d
Cleared Jun 02, 1983
API UNISCEPT PLUS AUTOINOCULATOR
K831341 · JTC
Analytical Products, Inc.
Immunology · 38d
Cleared Jun 02, 1983
AMES TDA N-ACETYL-PROCAINAMIDE TEST
K831399 · LAN
Miles Laboratories, Inc.
Immunology · 34d
Cleared Jun 02, 1983
AMES TDA PROCAINAMIDE TEST
K831400 · LAR
Miles Laboratories, Inc.
Immunology · 34d
Cleared Jun 02, 1983
VENTRE/ZYME IGE KIT
K831485 · DGC
Ventrex Laboratories, Inc.
Immunology · 24d
Cleared May 27, 1983
EMIT SRD MANUAL CORTISOL ASSAY
K831141 · CGR
Syva Co.
Immunology · 50d