510(k) K781769
- Device
- IRON 59 KIT
- Applicant
- RIA PRODUCTS, INC.
- 510(k) number
- K781769
- Product code
- JJA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-12-04
- Date received
- 1978-10-16
- Regulation
- 862.1410
- Classification name
- Radio-labeled Iron Method, Iron (non-heme)
- 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 JJA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K820253 | SIMUL-FER SERUM IRON TEST KIT | Diagnostic Reagents, Inc. | 1982-05-12 |
| K782159 | DIAGNOSTIC KIT, FERRITAB-FE-59 | Leeco Diagnostics, Inc. | 1979-02-01 |
| K760045 | KIT, RADIOASSAY, SERUM IRON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
Legacy Summary#
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FDA Review#
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