510(k) K780412
- Device
- Total Iron Binding Capacity
- Applicant
- DIAGNOSTIC CORP. OF AMERICA
- 510(k) number
- K780412
- Product code
- JQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-05-26
- Date received
- 1978-03-15
- 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 |
|---|---|---|---|
| K811954 | COMBO-FER IRON DIAGNOSTIC | Immuno Assay Corp. | 1981-07-27 |
| 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 |