FDA product code JJA: Radio-Labeled Iron Method, Iron (Non-Heme)
JJA is the FDA product code for radio-labeled iron method, iron (non-heme). It is a Class I device, regulated under 21 CFR 862.1410 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under JJA, from 4 different applicants. The average 510(k) review took 57 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Radio-Labeled Iron Method, Iron (Non-Heme) |
| Device class | Class I |
| Regulation | 21 CFR 862.1410 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJA clearance
Top JJA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Reagents, Inc. | 1 | 1982-05-12 |
| Leeco Diagnostics, Inc. | 1 | 1979-02-01 |
| Ria Products, Inc. | 1 | 1978-12-04 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1976-07-20 |
Most recent JJA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K820253 | Diagnostic Reagents, Inc. | SIMUL-FER SERUM IRON TEST KIT | 1982-05-12 | 103 |
| K782159 | Leeco Diagnostics, Inc. | DIAGNOSTIC KIT, FERRITAB-FE-59 | 1979-02-01 | 41 |
| K781769 | Ria Products, Inc. | IRON 59 KIT | 1978-12-04 | 49 |
| K760045 | Bd Becton Dickinson Vacutainer Systems Preanalytic | KIT, RADIOASSAY, SERUM IRON | 1976-07-20 | 35 |
Recalls for JJA devices
openFDA lists no recalls for product code JJA.
Frequently asked questions
What is FDA product code JJA?
JJA is the FDA product code for radio-labeled iron method, iron (non-heme). It is a Class I device, regulated under 21 CFR 862.1410 and reviewed by the Clinical Chemistry panel.
What device class is JJA?
Class I, regulation 21 CFR 862.1410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJA?
Across 4 cleared submissions the average was 57 days from receipt to decision (median 45).
Which companies have the most JJA clearances?
Diagnostic Reagents, Inc. (1); Leeco Diagnostics, Inc. (1); Ria Products, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JJA
- Run a recall and safety report across every JJA manufacturer
- Watch product code JJA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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