SIMUL-FER SERUM IRON TEST KIT
FDA 510(k) clearance K820253 · decided 1982-05-12
Clearance details
- K-number
- K820253
- Device name
- SIMUL-FER SERUM IRON TEST KIT
- Applicant
- Diagnostic Reagents, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-01-29
- Decision date
- 1982-05-12
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- JJA
- Device class
- 1
- Regulation number
- 862.1410
- 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 |
|---|---|---|
| DIAGNOSTIC KIT, FERRITAB-FE-59 (K782159) | Leeco Diagnostics, Inc. | 1979-02-01 |
| IRON 59 KIT (K781769) | Ria Products, Inc. | 1978-12-04 |
| KIT, RADIOASSAY, SERUM IRON (K760045) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.