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
3409–3432 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 16, 1980
MULTIPLE AUTO ANTIBODY TEST
K791996 · DBL
Meda Stat Diagnostics, Inc.
Immunology · 105d
Cleared Jan 11, 1980
TERRITIN RIA KIT
K792588 · JMG
Bd Becton Dickinson Vacutainer...
Immunology · 25d
Cleared Dec 31, 1979
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
K791455 · KTN
Volu Sol Medical Industries
Immunology · 147d
Cleared Dec 31, 1979
AGGLUTINOTEST-THYROGLOBULIN
K791458 · JZO
Volu Sol Medical Industries
Immunology · 147d
Cleared Dec 31, 1979
AGGLUTINOTEST-C-REACTIVE PROTEIN
K791461 · DCK
Volu Sol Medical Industries
Immunology · 147d
Cleared Dec 31, 1979
AGGLUTINOTEST-RHEUMATOID ARTHRITIS
K791507 · DHR
Volu Sol Medical Industries
Immunology · 152d
Cleared Dec 31, 1979
CENTRIA FERRITIN RIA
K792449 · DBF
Union Carbide Corp.
Immunology · 31d
Cleared Dec 27, 1979
ELECTRO-IMMUNO-QUANTITATION (EIQ)
K792472 · DAK
Icl Scientific
Immunology · 24d
Cleared Dec 18, 1979
FERRITIN RADIOIMMUNOASSAY
K792442 · DBF
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 19d
Cleared Dec 06, 1979
FERRITIN RIA KIT
K791860 · DBF
Cis Radiopharmaceuticals, Inc.
Immunology · 78d
Cleared Dec 06, 1979
RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN
K792314 · FAM
Icl Scientific
Immunology · 20d
Cleared Dec 04, 1979
TEMPTRONIC 100 WATER BATH
K792060 · JTQ
Sybron Corp.
Immunology · 50d
Cleared Nov 30, 1979
LAB-TEK ANA TEST KIT
K792184 · DHN
Miles Laboratories, Inc.
Immunology · 32d
Cleared Nov 30, 1979
CRPTELL
K792238 · DCK
Central Biological Co.
Immunology · 23d
Cleared Nov 27, 1979
ANTI-HUMAN IGG SERUM
K791281 · DEW
Diagnostica, Inc.
Immunology · 140d
Cleared Nov 27, 1979
ANTI-HUMAN LAMBDA SERUM
K791283 · DEH
Diagnostica, Inc.
Immunology · 140d
Cleared Nov 27, 1979
ANTI-HUMAN KAPPA SERUM
K791284 · DFH
Diagnostica, Inc.
Immunology · 140d
Cleared Nov 27, 1979
CORDIA RF
K792061 · DHR
Cordis Corp.
Immunology · 43d
Cleared Nov 27, 1979
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188 · CDX
Abbott Laboratories
Immunology · 27d
Cleared Nov 20, 1979
FOLLICLE STIMULATING HORMONE (FSH) KIT
K792063 · CGJ
Cis Radiopharmaceuticals, Inc.
Immunology · 36d
Cleared Nov 13, 1979
ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT
K791928 · DHN
Keith E. Abbott
Immunology · 47d
Cleared Nov 13, 1979
LANCER L-INA HUMAN REFERENCE SERUM
K792013 · JIX
Sherwood Medical Industries
Immunology · 39d
Cleared Nov 13, 1979
LANCER L-INA BUFFER, POLYMER, WASH SOLU
K792014 · JZW
Sherwood Medical Industries
Immunology · 39d
Cleared Nov 05, 1979
MONOJECT SICKLE CELL KIT
K791971 · GHM
Sherwood Medical Co.
Immunology · 34d