FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
K Number: K981436
·
Decision Apr 24, 1998
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
301
Applicant Total
38
Review Days
10
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Basic Information
- Device Name
- DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
- K Number
- K981436
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Casco Standards
- Date Received
- April 14, 1998
- Decision Date
- April 24, 1998
- Product Code
- JIX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | FDA class 2 | Clinical Chemistry |
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