SANDARE NITROPRUSSIDE TEST PROCEDURE
FDA 510(k) clearance K810514 · decided 1981-03-04
Clearance details
- K-number
- K810514
- Device name
- SANDARE NITROPRUSSIDE TEST PROCEDURE
- Applicant
- Sandare Chemical Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-25
- Decision date
- 1981-03-04
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- JLC
- Device class
- 1
- Regulation number
- 862.1240
- 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 |
|---|---|---|
| UROCYSTIN (K843382) | Mission Pharmacal Co. | 1985-01-08 |
Recalls involving this device
No recalls on record reference this clearance.