GLUCOSE-HK SYSTEM PACK TEST— 510(k) K812303
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K812303 for GLUCOSE-HK SYSTEM PACK TEST, Substantially Equivalent on 1981-09-01. Applicant: Boehringer Mannheim Corp.. Device class: 2.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- 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
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More clearances from Boehringer Mannheim Corp.
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