WAKO PHOSPHOLIPIDS TEST
FDA 510(k) clearance K801076 · decided 1980-06-30
Clearance details
- K-number
- K801076
- Device name
- WAKO PHOSPHOLIPIDS TEST
- Applicant
- Wako Pure Chemical Industries, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1980-05-07
- Decision date
- 1980-06-30
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- CEL
- Device class
- 1
- Regulation number
- 862.1575
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS (K905829) | Kamiya Biomedical Co. | 1991-01-30 |
| DU PONT ANALYST THYROID ROTOR (K884169) | The DU Pont Co. | 1989-01-24 |
Recalls involving this device
No recalls on record reference this clearance.