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
3313–3336 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 23, 1981
ANA TEST KIT
K811022 · DHN
Immuno-Diagnostic Products, Inc.
Immunology · 8d
Cleared Apr 14, 1981
THROMBOPLASTIN
K810350 · GJS
Pacific Hemostasis
Immunology · 63d
Cleared Apr 14, 1981
KALLESTAD HEP-2 CELL LINE SUBSTRATE
K810863 · DBM
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Apr 08, 1981
SCRIPPSYSTEM C3 RID KIT
K810501 · CZW
Scripps-Miles, Inc.
Immunology · 43d
Cleared Apr 08, 1981
SCRIPPSYSTEM C4 RID KIT
K810502 · DBI
Scripps-Miles, Inc.
Immunology · 43d
Cleared Apr 08, 1981
CRP SLIDE
K810862 · DCN
Syn-Kit, Inc.
Immunology · 8d
Cleared Mar 31, 1981
CEFOTAXIME 30 MCG. SENSITIVITY DISCS.
K810546 · JTN
Difco Laboratories, Inc.
Immunology · 32d
Cleared Mar 31, 1981
RPR CARD TEST SYSTEM
K810658 · GMQ
Beckman Instruments, Inc.
Immunology · 20d
Cleared Mar 31, 1981
QUALITROL #65057
K810725 · JJT
Harleco
Immunology · 14d
Cleared Mar 20, 1981
PHADEZYM IGE PRIST TEST
K810507 · DGC
Pharmacia, Inc.
Immunology · 24d
Cleared Mar 11, 1981
RHEUMATOID FACTOR REAGENT TEST KIT
K810306 · DHR
Beckman Instruments, Inc.
Immunology · 34d
Cleared Mar 11, 1981
RUBELLA ANTIBODIES TEST REAGENTS
K810309 · GOL
Calbiochem-Behring Corp.
Immunology · 34d
Cleared Mar 11, 1981
PHADEZYM RAST TEST
K810462 · DHB
Pharmacia, Inc.
Immunology · 19d
Cleared Feb 25, 1981
CORDIA A
K810046 · KHW
Cordis Corp.
Immunology · 44d
Cleared Feb 25, 1981
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
K810301 · DHN
Immuno Concepts, Inc.
Immunology · 21d
Cleared Feb 09, 1981
IMMUNOLOGY CONTROL SERUM
K810056 · DEW
Icl Scientific
Immunology · 27d
Cleared Feb 09, 1981
SCRIPPSERA ANA REFERENCE CONTROL SERA
K810081 · DHN
Scripps-Miles, Inc.
Immunology · 27d
Cleared Feb 09, 1981
SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
K810141 · DHR
Scripps-Miles, Inc.
Immunology · 19d
Cleared Feb 09, 1981
SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
K810221 · DHR
Scripps-Miles, Inc.
Immunology · 13d
Cleared Feb 09, 1981
SLE ANTI-N-DNA LATEX TEST
K810226 · DHC
Icl Scientific
Immunology · 13d
Cleared Jan 29, 1981
K/K (ASMA/ANA) UNIVERSAL BIOPAK
K802299 · DHN
Bioware Products
Immunology · 132d
Cleared Jan 28, 1981
SEROCLUSTER EIA PLATES
K803242 · JTC
Corning Costar Corp.
Immunology · 36d
Cleared Jan 28, 1981
SEROCLUSTER FLEXIBLE VINYL U & V PL.
K803243 · JTC
Corning Costar Corp.
Immunology · 36d
Cleared Jan 26, 1981
AIP SYSTEM-METHOD FOR IGM
K803251 · DFT
Icl Scientific
Immunology · 34d