FDA product code JFH: Acid Phosphatase (Prostatic), Tartrate Inhibited
JFH is the FDA product code for acid phosphatase (prostatic), tartrate inhibited. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel. FDA has cleared 45 510(k) submissions under JFH, from 33 different applicants. The average 510(k) review took 65 days (median 59). FDA has posted 1 recall for JFH devices.
Classification
| Field | Value |
|---|---|
| Device name | Acid Phosphatase (Prostatic), Tartrate Inhibited |
| Device class | Class II |
| Regulation | 21 CFR 862.1020 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JFH clearance
Top JFH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 6 | 2000-02-23 |
| Hybritech, Inc. | 4 | 1992-07-30 |
| Abbott Laboratories | 3 | 1993-01-13 |
| Biogenex Laboratories | 2 | 1982-04-14 |
| Leeco Diagnostics, Inc. | 2 | 1981-02-10 |
28 more applicants have JFH clearances. See the full list in Caduvo.
Most recent JFH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000257 | Diagnostic Products Corp. | IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 | 2000-02-23 | 27 |
| K981573 | United Biotech, Inc. | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE | 1998-09-15 | 134 |
| K964756 | Wano-Tech Corp. | PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT | 1997-04-23 | 147 |
| K931701 | Diagnostic Products Corp. | IMMULITE PAP | 1994-01-27 | 296 |
| K925377 | Abbott Laboratories | IMX PAP | 1993-01-13 | 82 |
Recalls for JFH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-05.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code JFH?
JFH is the FDA product code for acid phosphatase (prostatic), tartrate inhibited. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel.
What device class is JFH?
Class II, regulation 21 CFR 862.1020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JFH?
Across 45 cleared submissions the average was 65 days from receipt to decision (median 59).
Which companies have the most JFH clearances?
Diagnostic Products Corp. (6); Hybritech, Inc. (4); Abbott Laboratories (3); Biogenex Laboratories (2); Leeco Diagnostics, Inc. (2).
Have JFH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code JFH
- Run a recall and safety report across every JFH manufacturer
- Watch product code JFH 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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