SANDARE ACID PHOSPHATASE PROCEDURE
FDA 510(k) clearance K842516 · decided 1984-08-17
Clearance details
- K-number
- K842516
- Device name
- SANDARE ACID PHOSPHATASE PROCEDURE
- Applicant
- Sandare Chemical Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-10
- Decision date
- 1984-08-17
- Days to decision
- 38 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 |
|---|---|---|
| TEST, ACID PHOSPHATASE (K760161) | Princeton Biomedix | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.