FDA product code CGJ: Radioimmunoassay, Follicle-Stimulating Hormone
CGJ is the FDA product code for radioimmunoassay, follicle-stimulating hormone. It is a Class I device, regulated under 21 CFR 862.1300 and reviewed by the Clinical Chemistry panel. FDA has cleared 88 510(k) submissions under CGJ, from 61 different applicants. The average 510(k) review took 55 days (median 44). FDA has posted 9 recalls for CGJ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Follicle-Stimulating Hormone |
| Device class | Class I |
| Regulation | 21 CFR 862.1300 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CGJ clearance
Top CGJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medix Biotech, Inc. | 4 | 1991-12-18 |
| Amersham Corp. | 4 | 1988-07-21 |
| Abbott Laboratories | 3 | 1994-06-21 |
| Diagnostic Products Corp. | 3 | 1989-10-31 |
| Nichols Institute Diagnostics | 3 | 1988-04-28 |
56 more applicants have CGJ clearances. See the full list in Caduvo.
Most recent CGJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052662 | Ind Diagnostic, Inc. | ONE STEP FSH MENOPAUSAL TEST | 2005-11-30 | 64 |
| K043599 | Phamatech, Inc. | MOMENTS MENOPAUSE CHECK, MODEL 9113 | 2005-02-25 | 58 |
| K041165 | ACON Laboratories, Inc. | FSH MENOPAUSE PREDICTOR TEST | 2004-06-17 | 44 |
| K040575 | Phamatech, Inc. | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | 2004-05-20 | 77 |
| K030058 | Early Detect, Inc. | EARLYDETECT MENOPAUSE TEST FOR FSH | 2003-07-30 | 204 |
Recalls for CGJ devices
9 product recalls in 9 recall events; 2 initiated in the last five years and 4 still open. Most recent: 2023-05-22.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code CGJ?
CGJ is the FDA product code for radioimmunoassay, follicle-stimulating hormone. It is a Class I device, regulated under 21 CFR 862.1300 and reviewed by the Clinical Chemistry panel.
What device class is CGJ?
Class I, regulation 21 CFR 862.1300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CGJ?
Across 88 cleared submissions the average was 55 days from receipt to decision (median 44).
Which companies have the most CGJ clearances?
Medix Biotech, Inc. (4); Amersham Corp. (4); Abbott Laboratories (3); Diagnostic Products Corp. (3); Nichols Institute Diagnostics (3).
Have CGJ devices been recalled?
Yes: 9 product recalls across 9 recall events; the most recent began 2023-05-22.
Next steps
- Run an FDA pathway report with predicate devices for product code CGJ
- Run a recall and safety report across every CGJ manufacturer
- Watch product code CGJ 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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