FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
K Number: K974859
·
Decision Jan 22, 1998
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
110
Applicant Total
66
Review Days
24
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Basic Information
- Device Name
- LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
- K Number
- K974859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Chemicals , Ltd.
- Date Received
- December 29, 1997
- Decision Date
- January 22, 1998
- Product Code
- CFJ
- 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 |
|---|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | FDA class 2 | Clinical Chemistry |
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