FDA product code JMF: Radioimmunoassay, Human Placental Lactogen
JMF is the FDA product code for radioimmunoassay, human placental lactogen. It is a Class II device, regulated under 21 CFR 862.1585 and reviewed by the Clinical Chemistry panel. FDA has cleared 11 510(k) submissions under JMF, from 10 different applicants. The average 510(k) review took 45 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Human Placental Lactogen |
| Device class | Class II |
| Regulation | 21 CFR 862.1585 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JMF clearance
Top JMF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 2 | 1995-03-10 |
| Amersham Corp. | 1 | 1984-04-04 |
| Corning Medical & Scientific | 1 | 1982-12-28 |
| Armkel, LLC | 1 | 1981-05-29 |
| Syn-Kit, Inc. | 1 | 1980-11-12 |
5 more applicants have JMF clearances. See the full list in Caduvo.
Most recent JMF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944933 | Diagnostic Products Corp. | IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) | 1995-03-10 | 155 |
| K840588 | Amersham Corp. | AMERLEX HUMAN PLACENTAL LACTOGEN | 1984-04-04 | 55 |
| K823292 | Corning Medical & Scientific | IMMOPHASE TM HPL RADIOIMMUNOASSAY | 1982-12-28 | 53 |
| K823201 | Diagnostic Products Corp. | HUMAN PLACENTAL LACTOGEN KIT | 1982-11-29 | 34 |
| K811370 | Armkel, LLC | NATAL-TEC HPL | 1981-05-29 | 15 |
Recalls for JMF devices
openFDA lists no recalls for product code JMF.
Frequently asked questions
What is FDA product code JMF?
JMF is the FDA product code for radioimmunoassay, human placental lactogen. It is a Class II device, regulated under 21 CFR 862.1585 and reviewed by the Clinical Chemistry panel.
What device class is JMF?
Class II, regulation 21 CFR 862.1585. Typical premarket route: 510(k).
How long does a 510(k) take for product code JMF?
Across 11 cleared submissions the average was 45 days from receipt to decision (median 35).
Which companies have the most JMF clearances?
Diagnostic Products Corp. (2); Amersham Corp. (1); Corning Medical & Scientific (1); Armkel, LLC (1); Syn-Kit, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JMF
- Run a recall and safety report across every JMF manufacturer
- Watch product code JMF 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times