FDA product code JZJ: Prealbumin, Antigen, Antiserum, Control
JZJ is the FDA product code for prealbumin, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5060 and reviewed by the Immunology panel. FDA has cleared 11 510(k) submissions under JZJ, from 9 different applicants. The average 510(k) review took 111 days (median 51). FDA has posted 1 recall for JZJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Prealbumin, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5060 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZJ clearance
Top JZJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kent Laboratories, Inc. | 2 | 1995-06-01 |
| Atlantic Antibodies | 2 | 1988-11-02 |
| Randox Laboratories, Ltd. | 1 | 2000-04-13 |
| Boehringer Mannheim Corp. | 1 | 1998-01-09 |
| The Binding Site, Ltd. | 1 | 1991-12-20 |
4 more applicants have JZJ clearances. See the full list in Caduvo.
Most recent JZJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000661 | Randox Laboratories, Ltd. | RANDOX PREALBUMIN | 2000-04-13 | 45 |
| K972638 | Boehringer Mannheim Corp. | TINA-QUANT PREALBUMIN | 1998-01-09 | 178 |
| K951966 | Kent Laboratories, Inc. | HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT | 1995-06-01 | 35 |
| K913672 | The Binding Site, Ltd. | PREALBUMIN IMMUNOLOGICAL NL TEST KIT | 1991-12-20 | 123 |
| K884298 | Atlantic Antibodies | SPQ(TM) TEST SYSTEM FOR MICROALBUMIN | 1988-11-02 | 21 |
Recalls for JZJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-11-10.
Frequently asked questions
What is FDA product code JZJ?
JZJ is the FDA product code for prealbumin, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5060 and reviewed by the Immunology panel.
What device class is JZJ?
Class I, regulation 21 CFR 866.5060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZJ?
Across 11 cleared submissions the average was 111 days from receipt to decision (median 51).
Which companies have the most JZJ clearances?
Kent Laboratories, Inc. (2); Atlantic Antibodies (2); Randox Laboratories, Ltd. (1); Boehringer Mannheim Corp. (1); The Binding Site, Ltd. (1).
Have JZJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-11-10.
Next steps
- Run an FDA pathway report with predicate devices for product code JZJ
- Run a recall and safety report across every JZJ manufacturer
- Watch product code JZJ 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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