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
4657–4680 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 29, 1996
EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
K963763 · JGS
Medica Corp.
Chemistry · 71d
Cleared Nov 29, 1996
AVL COMPACT 3 PH/BLOOD GAS ANALYZER
K963964 · CHL
Avl Scientific Corp.
Chemistry · 58d
Cleared Nov 27, 1996
EASYLYTE CALCIUM/CHLORIDE ANALYZER
K963694 · JFP
Medica Corp.
Chemistry · 72d
Cleared Nov 27, 1996
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3...
K964308 · KHQ
Johnson & Johnson Clinical...
Chemistry · 29d
Cleared Nov 27, 1996
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL...
K964310 · CDP
Johnson & Johnson Clinical...
Chemistry · 29d
Cleared Nov 27, 1996
AIA-PACK FOLATE ASSAY
K964349 · CGN
Tosoh Medics, Inc.
Chemistry · 27d
Cleared Nov 25, 1996
CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST
K964155 · JHI
Genzyme Diagnostics
Chemistry · 40d
Cleared Nov 25, 1996
CONTRAST STRIP HCG
K964156 · JHI
Genzyme Diagnostics
Chemistry · 40d
Cleared Nov 22, 1996
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY...
K964278 · JJX
Clinical Controls, Inc.
Chemistry · 25d
Cleared Nov 22, 1996
PARAMAX AMMONIA AND AMMONIA BLANK REAGENT
K964565 · JIF
Dade Intl., Inc.
Chemistry · 8d
Cleared Nov 21, 1996
N PROTEIN STRANDARD SL
K964062 · JIX
Behring Diagnostics, Inc.
Chemistry · 42d
Cleared Nov 20, 1996
RDI LDL PRECIPITATION REAGENT
K964063 · MRR
Reference Diagnostics, Inc.
Chemistry · 41d
Cleared Nov 20, 1996
RDI LIPIDIRECT MAGNETIC LDL REAGENT
K964064 · MRR
Reference Diagnostics, Inc.
Chemistry · 41d
Cleared Nov 18, 1996
BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS
K961566 · JLW
Biocircuits Corp.
Chemistry · 209d
Cleared Nov 18, 1996
TOTAL IRON (NITRO-PAPS) REAGENT SET
K961588 · JIY
Pointe Scientific, Inc.,
Chemistry · 208d
Cleared Nov 18, 1996
MINI STRIP/SERUM HCG
K963132 · JHI
International Newtech Development, Inc.
Chemistry · 98d
Cleared Nov 18, 1996
PS-UNIT CASSETTE/SERUM HCG
K963133 · JHI
International Newtech Development, Inc.
Chemistry · 98d
Cleared Nov 18, 1996
FACT PLUS PREGNANCY TEST
K964108 · LCX
Direct Access Diagnostics
Chemistry · 34d
Cleared Nov 13, 1996
IL SYNTHESIS
K963800 · CHL
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Nov 08, 1996
AIA-PACK FT3 ASSAY
K963687 · CDP
Tosoh Medics, Inc.
Chemistry · 53d
Cleared Nov 08, 1996
HEMOCUE GLUCOLIN
K963909 · JJX
Direct Solutions
Chemistry · 39d
Cleared Nov 07, 1996
PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH...
K960855 · CGA
Home Diagnostics, Inc.
Chemistry · 251d
Cleared Nov 07, 1996
CARDIAC STATUS TROPONIN I
K963513 · MMI
Princeton BioMeditech Corp.
Chemistry · 65d
Cleared Nov 07, 1996
NATURALE HCG PREGNANCY TES
K964002 · LCX
Mizuho USA, Inc.
Chemistry · 31d