GLUCOSE (HEXOKINASE)— 510(k) K874846
Substantially EquivalentTech-Co, Inc.
FDA 510(k) clearance K874846 for GLUCOSE (HEXOKINASE), Substantially Equivalent on 1988-03-03. Applicant: Tech-Co, Inc.. Device class: 2.
Clearance details
- Applicant
- Tech-Co, 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
- Oak Park, MI, US
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