DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109— 510(k) K981436
Substantially EquivalentCasco Standards
FDA 510(k) clearance K981436 for DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109, Substantially Equivalent on 1998-04-24. Applicant: Casco Standards. Device class: 2.
Clearance details
- Applicant
- Casco Standards
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Portland, ME, US
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More clearances from Casco Standards
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