FERRO-QUANT TM FE 59 TEST KIT
FDA 510(k) clearance K800868 · decided 1980-04-29
Clearance details
- K-number
- K800868
- Device name
- FERRO-QUANT TM FE 59 TEST KIT
- Applicant
- Mallinckrodt Critical Care
- Decision
- Substantially Equivalent
- Date received
- 1980-04-17
- Decision date
- 1980-04-29
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- JQG
- Device class
- 1
- Regulation number
- 862.1415
- 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 |
|---|---|---|
| COMBO-FER IRON DIAGNOSTIC (K811954) | Immuno Assay Corp. | 1981-07-27 |
| FERRITIRON KIT CAT. #RP-1100 (K800710) | Ria Products, Inc. | 1980-05-14 |
| SPINSEP-FE59 (K790133) | Nuclear Diagnostics, Inc. | 1979-03-02 |
| TOTAL IRON BINDING CAPACITY (K780412) | Diagnostic Corp. of America | 1978-05-26 |
Recalls involving this device
No recalls on record reference this clearance.