FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
K Number: K905829
·
Decision Jan 30, 1991
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
43
Review Days
30
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Basic Information
- Device Name
- DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
- K Number
- K905829
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1575
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Kamiya Biomedical Co.
- Date Received
- December 31, 1990
- Decision Date
- January 30, 1991
- Product Code
- CEL
- 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 |
|---|---|---|---|
| CEL | Ammonium Molybdate And Ammonium Vanadate, Phospholipids | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEL), ordered by most recent decision date.
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