JJA — Radio-Labeled Iron Method, Iron (Non-Heme) Class I
FDA product code JJA covers "Radio-Labeled Iron Method, Iron (Non-Heme)", a Class I medical device regulated under 21 CFR 862.1410. Submissions are reviewed by the Clinical Chemistry panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JJA
- Device Class
- Class I
- Regulation Number
- 862.1410
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K820253 | diagnostic reagents | SIMUL-FER SERUM IRON TEST KIT | May 12, 1982 |
| K782159 | leeco diagnostics | DIAGNOSTIC KIT, FERRITAB-FE-59 | February 1, 1979 |
| K781769 | ria products | IRON 59 KIT | December 4, 1978 |
| K760045 | bd becton dickinson vacutainer systems preanalytic | KIT, RADIOASSAY, SERUM IRON | July 20, 1976 |