TEST, ACID PHOSPHATASE
FDA 510(k) clearance K760161 · decided 1976-07-20
Clearance details
- K-number
- K760161
- Device name
- TEST, ACID PHOSPHATASE
- Applicant
- Princeton Biomedix
- Decision
- Substantially Equivalent
- Date received
- 1976-07-02
- Decision date
- 1976-07-20
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- CJR
- Device class
- 2
- Regulation number
- 862.1020
- 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 |
|---|---|---|
| SANDARE ACID PHOSPHATASE PROCEDURE (K842516) | Sandare Chemical Co., Inc. | 1984-08-17 |
Recalls involving this device
No recalls on record reference this clearance.