PROTOFLUOR Z
FDA 510(k) clearance K871499 · decided 1987-08-25
Clearance details
- K-number
- K871499
- Device name
- PROTOFLUOR Z
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1987-04-16
- Decision date
- 1987-08-25
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- JKJ
- Device class
- 1
- Regulation number
- 862.1595
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Beaumont, 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 |
|---|---|---|
| PROTOFLUOR Z (K893038) | Helena Laboratories | 1989-11-17 |
| QUANTITATIVE DETERMINATION OF PORPHYRINS (K780455) | Whale Scientific, Inc. | 1978-07-27 |
Recalls involving this device
No recalls on record reference this clearance.