TECHNICON CHEM 1 PLASMA GLUCOSE— 510(k) K914794
Substantially EquivalentHeraeus Kulzer, Inc.
FDA 510(k) clearance K914794 for TECHNICON CHEM 1 PLASMA GLUCOSE, Substantially Equivalent on 1991-12-18. Applicant: Heraeus Kulzer, Inc.. Device class: 2.
Clearance details
- Applicant
- Heraeus Kulzer, 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
- Tarrytown, NY, US
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