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
3073–3096 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 20, 1983
SERA-TEK MYCOPLASMA ANTIBODY TEST
K832132 · GSB
Miles Laboratories, Inc.
Immunology · 81d
Cleared Sep 12, 1983
ANA MICROZYME TEST SYS #1610
K832675 · DAA
Clinical Sciences, Inc.
Immunology · 34d
Cleared Aug 31, 1983
IDT ANA STIQ ASSAY
K832383 · DHN
Intl. Diagnostic Technology
Immunology · 43d
Cleared Aug 26, 1983
FIAX CRP TEST KIT
K832054 · DCK
Intl. Diagnostic Technology
Immunology · 60d
Cleared Aug 11, 1983
ANTI-N DNA ANTIBODY TEST KIT
K832031 · KTL
Breit Laboratories, Inc.
Immunology · 49d
Cleared Aug 08, 1983
CMV RQ BIO-ENZABEAD KIT
K831343 · LFZ
Litton Bionetics
Immunology · 105d
Cleared Aug 08, 1983
ALLERGEN IMMUNOSORBENTS IP SPECIFIC E
K831496
Diagnostic Reagent Tech.
Immunology · 90d
Cleared Jul 28, 1983
DNA FLOR
K831408 · DHN
Medastat Scientific Corp.
Immunology · 87d
Cleared Jul 28, 1983
REVOLUTION RADIAL IMMUNODIFFUSION PLATE
K831811 · JZQ
Calbiochem-Behring Corp.
Immunology · 52d
Cleared Jul 26, 1983
POLYCHACO FIA-ABS TEST FOR SYPHILIS
K831296 · JWL
Parasitic Disease Consultants
Immunology · 97d
Cleared Jul 19, 1983
FLUORESCEIN CONJUGATED IMMUNOGLOBULIN
K831903 · DES
Dako Corp.
Immunology · 35d
Cleared Jul 19, 1983
RABBIT ANTISERUM TO HUMAN KAPPA LIGHT
K831904 · DEO
Dako Corp.
Immunology · 35d
Cleared Jul 19, 1983
RABBIT ANTISERUM TO HUMAN C4
K831906 · DBI
Dako Corp.
Immunology · 35d
Cleared Jul 19, 1983
RABBIT ANTISERUM TO HUMAN IGM
K831907 · DFS
Dako Corp.
Immunology · 35d
Cleared Jul 18, 1983
ANTI-ENA TEST
K831292 · LKO
Meloy Laboratories, Inc.
Immunology · 89d
Cleared Jul 18, 1983
LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-
K831774 · DGO
Diagnostic Reagent Tech.
Immunology · 46d
Cleared Jul 18, 1983
FLUORESCEIN CONJUGATED IMMUNOGLOBIN-
K831902 · DDZ
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
RABBITT ANTISERUM TO HUMAN C3C
K831905 · CZW
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
RABBIT ANTISERUM TO HUMAN IGG
K831908 · DGK
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
RABBIT ANTISERUM TO HUMAN IGA
K831909 · CZN
Dako Corp.
Immunology · 34d
Cleared Jul 18, 1983
ANTINUCLEAR ANTIBODY TEST KIT
K831927 · DAA
Breit Laboratories, Inc.
Immunology · 33d
Cleared Jul 18, 1983
LEAP RHEUMATOID FACTOR TEST KIT
K831941 · DHR
Cooper Diagnostics, Inc.
Immunology · 32d
Cleared Jun 30, 1983
SERO/TEX RED CELL RF TEST
K831597 · DHR
Texas Immunology, Inc.
Immunology · 44d
Cleared Jun 22, 1983
HCG-CHECK
K831466 · JHJ
Diagnostic Technology, Inc.
Immunology · 47d