UROCYSTIN
FDA 510(k) clearance K843382 · decided 1985-01-08
Clearance details
- K-number
- K843382
- Device name
- UROCYSTIN
- Applicant
- Mission Pharmacal Co.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-28
- Decision date
- 1985-01-08
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- JLC
- Device class
- 1
- Regulation number
- 862.1240
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Antonio, TX, 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 NITROPRUSSIDE TEST PROCEDURE (K810514) | Sandare Chemical Co., Inc. | 1981-03-04 |
Recalls involving this device
No recalls on record reference this clearance.