FDA product code JHJ: Agglutination Method, Human Chorionic Gonadotropin
JHJ is the FDA product code for agglutination method, human chorionic gonadotropin. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel. FDA has cleared 96 510(k) submissions under JHJ, from 54 different applicants. The average 510(k) review took 70 days (median 48). FDA has posted 3 recalls for JHJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Agglutination Method, Human Chorionic Gonadotropin |
| Device class | Class II |
| Regulation | 21 CFR 862.1155 |
| 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 JHJ clearance
Top JHJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Organon, Inc. | 11 | 1984-08-24 |
| Armkel, LLC | 6 | 1986-09-29 |
| Stanbio Laboratory | 4 | 1984-09-21 |
| Texas Immunology, Inc. | 3 | 1988-02-02 |
| Cal-Tech Diagnostics, Inc. | 3 | 1986-11-05 |
49 more applicants have JHJ clearances. See the full list in Caduvo.
Most recent JHJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972606 | Immunostics Inc., | PREGNACOL PREGNANCY TEST | 1997-08-29 | 49 |
| K921968 | Tech-Co, Inc. | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | 1996-06-28 | 1523 |
| K935863 | Sa Scientific, Inc. | SAS(TM) DIRECT MONOCLONAL HCG | 1994-02-24 | 83 |
| K926112 | J.S. Medical Assoc. | ACCUTEX BETA-HCG TEST | 1993-07-28 | 237 |
| K930609 | Sa Scientific, Inc. | SAS(TM) MONOCLONAL HCG-SLIDE | 1993-03-29 | 52 |
Recalls for JHJ devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 3 still open. Most recent: 2019-01-10.
| Year | Recalls |
|---|---|
| 2019 | 3 |
Frequently asked questions
What is FDA product code JHJ?
JHJ is the FDA product code for agglutination method, human chorionic gonadotropin. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel.
What device class is JHJ?
Class II, regulation 21 CFR 862.1155. Typical premarket route: 510(k).
How long does a 510(k) take for product code JHJ?
Across 96 cleared submissions the average was 70 days from receipt to decision (median 48).
Which companies have the most JHJ clearances?
Organon, Inc. (11); Armkel, LLC (6); Stanbio Laboratory (4); Texas Immunology, Inc. (3); Cal-Tech Diagnostics, Inc. (3).
Have JHJ devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2019-01-10.
Next steps
- Run an FDA pathway report with predicate devices for product code JHJ
- Run a recall and safety report across every JHJ manufacturer
- Watch product code JHJ 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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