FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WAKO PHOSPHOLIPIDS TEST
K Number: K801076
·
Decision Jun 30, 1980
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
6
Review Days
54
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Basic Information
- Device Name
- WAKO PHOSPHOLIPIDS TEST
- K Number
- K801076
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1575
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Wako Pure Chemical Industries, Ltd.
- Date Received
- May 7, 1980
- Decision Date
- June 30, 1980
- 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.
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DU PONT ANALYST THYROID ROTOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Wako Pure Chemical Industries, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K842221 | WAKO GLUCOSE C | Jul 12, 1984 | Substantially Equivalent |
| K813366 | AMMONIA TEST | Dec 22, 1981 | Substantially Equivalent |
| K801891 | WAKO TRIGLYCERIDE-G TEST | Sep 16, 1980 | Substantially Equivalent |
| K801834 | WAKO HDL CHOLESTEROL TEST | Sep 16, 1980 | Substantially Equivalent |
| K791597 | WAKO TRIGLYCERIDE | Sep 17, 1979 | Substantially Equivalent |