GLUCOSE (HEXOKINASE)— 510(k) K011900
Substantially EquivalentJas Diagnostics, Inc.
FDA 510(k) clearance K011900 for GLUCOSE (HEXOKINASE), Substantially Equivalent on 2001-07-31. Applicant: Jas Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Jas Diagnostics, Inc.
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code CFR
view all- K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
- K252357 — Glucose2
- K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
- K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
- K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
More clearances from Jas Diagnostics, Inc.
view all- K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
- K080623 — CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
- K080618 — DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
- K022519 — LDL CHOLESTEROL (AUTOMATED)
- K021671 — JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
Recalls naming K011900
K-number listed on FDA's recall record- Z-0827-2015 — Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
- Z-1873-2014 — Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011900.
Data sourced from openFDA. This site is unofficial and independent of the FDA.