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: Chemistry ×
13,237 results
9169–9192 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 30, 1985
DART CK-MB REAGENT SYSTEM
K854708 · JHS
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Dec 25, 1985
IN VITRO TEST DETERMINATION OF SGPT(ALT)
K854186 · CKA
Clinical Data, Inc.
Chemistry · 71d
Cleared Dec 19, 1985
QUANTTEST TOTAL PROTEIN ASSAY
K853932 · CEK
Quantimetrix Corp.
Chemistry · 86d
Cleared Dec 19, 1985
DSL ACTIVE TESTOSTERONE RIA (DSL #4000)
K854671 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 28d
Cleared Dec 19, 1985
DSL ANDROSTENDIONE RIA (DSL #4200)
K854674 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 28d
Cleared Dec 19, 1985
NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926
K854718 · CIX
Nobel Scientific Industries, Inc.
Chemistry · 27d
Cleared Dec 19, 1985
ABSORBANCE (ABS) TEST PAK
K854784 · JIT
Diagnostic Systems
Chemistry · 20d
Cleared Dec 17, 1985
OVUTIME OVULATION PREDICTOR TEST
K853142 · CEP
Advanced Care Products
Chemistry · 141d
Cleared Dec 13, 1985
RAICHEM CO2 REAGENT
K854544 · KHS
Reagents Applications, Inc.
Chemistry · 30d
Cleared Dec 13, 1985
DSL PROGESTERONE RIA (DSL #3400)
K854649 · JLS
Diagnostic Systems Laboratories, Inc.
Chemistry · 24d
Cleared Dec 13, 1985
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
K854650 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 24d
Cleared Dec 13, 1985
PARAAMAX CHLORIDE DETERMINATION BY ISE
K854651 · CGJ
American Dade
Chemistry · 24d
Cleared Dec 10, 1985
QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT
K853930 · CEK
Quantimetrix Corp.
Chemistry · 77d
Cleared Dec 09, 1985
LIFE WATCH RESPIRATORY MONITOR
K853840 · CHL
The Perkin-Elmer Corp.
Chemistry · 84d
Cleared Dec 05, 1985
LBK 1244 DELFIA HCG KIT
K852760 · JHI
Lkb Instruments, Inc.
Chemistry · 160d
Cleared Dec 05, 1985
REPLACEMENT PUMP TUBING
K853621 · JJE
Shaban Mfg. Co.
Chemistry · 98d
Cleared Dec 05, 1985
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE
K854057 · JHO
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Dec 05, 1985
IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY)
K854104 · JHI
Immunchem Corp.
Chemistry · 58d
Cleared Dec 05, 1985
TERUMO SENSIBEAD EIA COLORIMETER
K854210 · JJQ
Terumo Medical Corp.
Chemistry · 50d
Cleared Dec 05, 1985
PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT
K854324 · CDX
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 38d
Cleared Dec 05, 1985
ULTRAZYME PLUS & SYSTEMATE LDH
K854585 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Dec 05, 1985
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.
K854608 · CHL
Nova Biomedical Corp.
Chemistry · 17d
Cleared Dec 04, 1985
ELECTROLYTE ANALYZER SERA-252
K853405 · CHL
Horiba Instruments, Inc.
Chemistry · 114d
Cleared Dec 04, 1985
CK(OPTIMIZED) REAGENT
K854501 · CGS
Sigma Diagnostics, Inc.
Chemistry · 22d