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
2929–2952 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 05, 1984
FIAX HAPTOGLOBIN TEST KIT
K843570 · DAB
Intl. Diagnostic Technology
Immunology · 24d
Cleared Oct 04, 1984
NEW ALLERG. COATED MICROFILTER WELL STRI
K843302 · DHB
Diagnostic Reagent Tech.
Immunology · 42d
Cleared Oct 01, 1984
AMIZYME-C TRACHOMATIS TEST KIT
K842525 · LJP
Amico Lab, Inc.
Immunology · 95d
Cleared Oct 01, 1984
EPSILON HCG TEST KIT MONOCLONAL
K842654 · JHI
Beckman Instruments, Inc.
Immunology · 83d
Cleared Oct 01, 1984
ANTI-CHLAMYDIA TRACHOMATIS KIT
K842658 · LJP
Amico Lab, Inc.
Immunology · 83d
Cleared Oct 01, 1984
ENCORE IGE REAGENT
K843408 · DGC
Hybritech, Inc.
Immunology · 31d
Cleared Sep 26, 1984
PHENYTOIN KIT FLUORESCENCE POLARIZATION
K842586 · LGR
Windsor Laboratories, Inc.
Immunology · 85d
Cleared Sep 26, 1984
STRATUS LIDOCAINE FLUOROMETRIC ENZYME
K843184 · KLR
American Dade
Immunology · 44d
Cleared Sep 20, 1984
AMIZYME-ANA TEST KIT
K842532 · LJM
Amico Lab, Inc.
Immunology · 84d
Cleared Sep 20, 1984
AMIZYME-ANDNA TEST KIT
K842533 · LJM
Amico Lab, Inc.
Immunology · 84d
Cleared Sep 17, 1984
AUTOFLUOR IV SYSTEM
K843181 · DBM
Tech America Diagnostics
Immunology · 35d
Cleared Sep 17, 1984
FIAX 100 FLUOROMETER
K843356 · JZT
Intl. Diagnostic Technology
Immunology · 21d
Cleared Sep 14, 1984
NMS 1043 ENZYME IMMUNOASSAY KIT
K842499 · JHI
Nms Pharmaceuticals, Inc.
Immunology · 80d
Cleared Sep 04, 1984
VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC
K843230 · JFH
Ventrex Laboratories, Inc.
Immunology · 18d
Cleared Aug 28, 1984
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
K842468 · CZP
Miles Laboratories, Inc.
Immunology · 64d
Cleared Aug 28, 1984
TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM
K842470 · DFH
Miles Laboratories, Inc.
Immunology · 64d
Cleared Aug 28, 1984
AMIZYME-LEISHMANIA SPP. TEST KIT
K842526 · LOO
Amico Lab, Inc.
Immunology · 61d
Cleared Aug 28, 1984
ANTI-TOXOPLASMA GONDII KIT
K842664 · GLZ
Amico Lab, Inc.
Immunology · 49d
Cleared Aug 28, 1984
FIAX TOTAL IGE TEST KIT
K842749 · DGP
Intl. Diagnostic Technology
Immunology · 46d
Cleared Aug 28, 1984
PMK PRIMARY MONKEY KIDNEY-CELLS
K842833 · KJR
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 39d
Cleared Aug 28, 1984
HEP-2 CELLS
K842834 · KJR
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 39d
Cleared Aug 23, 1984
SERIMM SURE ASO-CHEK CONTROL SERUM
K842839 · GTQ
Analytical Products, Inc.
Immunology · 34d
Cleared Aug 21, 1984
ADP NDNA IFA TEST
K842707 · KTL
Apple Diagnostic Products
Immunology · 40d
Cleared Aug 16, 1984
STREPTEX DIRECT A ZL14
K842827 · GTZ
Wellcome Diagnostics
Immunology · 27d