TOTAL ESTROGENS KIT BY RIA
FDA 510(k) clearance K791651 · decided 1979-09-27
Clearance details
- K-number
- K791651
- Device name
- TOTAL ESTROGENS KIT BY RIA
- Applicant
- Radioassay Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-08-21
- Decision date
- 1979-09-27
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- JMD
- Device class
- 1
- Regulation number
- 862.1275
- 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 |
|---|---|---|
| ANALYZER, SERUM IRON & TOTAL IRON BINDIN (K781009) | Environmental Sciences Assoc., Inc. | 1978-07-27 |
Recalls involving this device
No recalls on record reference this clearance.