FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)
K Number: K790248
·
Decision Apr 4, 1979
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
110
Applicant Total
38
Review Days
55
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Basic Information
- Device Name
- NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)
- K Number
- K790248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Laboratories
- Date Received
- February 8, 1979
- Decision Date
- April 4, 1979
- 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 |
Similar 510(k) Clearances
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ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
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LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
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LIQUID LDH-L REAGENT SET
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LACTATE DEHYDROGENASE (LD)
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