510(k) K811954
- Device
- COMBO-FER IRON DIAGNOSTIC
- Applicant
- IMMUNO ASSAY CORP.
- 510(k) number
- K811954
- Product code
- JQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-27
- Date received
- 1981-07-08
- Regulation
- 862.1415
- Classification name
- Radiometric, Fe59, Iron Binding Capacity
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JQG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K800710 | FERRITIRON KIT CAT. #RP-1100 | Ria Products, Inc. | 1980-05-14 |
| K800868 | FERRO-QUANT TM FE 59 TEST KIT | Mallinckrodt Critical Care | 1980-04-29 |
| K790133 | SPINSEP-FE59 | Nuclear Diagnostics, Inc. | 1979-03-02 |
| K780412 | TOTAL IRON BINDING CAPACITY | Diagnostic Corp. of America | 1978-05-26 |
Legacy Summary#
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FDA Review#
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