DATA-ZYME GLUCOSE HEXOKINASE UV— 510(k) K801052
Substantially EquivalentData Medical Associates, Inc.
FDA 510(k) clearance K801052 for DATA-ZYME GLUCOSE HEXOKINASE UV, Substantially Equivalent on 1980-05-23. Applicant: Data Medical Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- Data Medical Associates, 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
- Mchenry, IL, 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 Data Medical Associates, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.