FDA product code GNC: Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
GNC is the FDA product code for antigens, febrile, slide and tube, all groups, salmonella spp.. It is a Class II device, regulated under 21 CFR 866.3550 and reviewed by the Microbiology panel. FDA has cleared 60 510(k) submissions under GNC, from 5 different applicants. The average 510(k) review took 76 days (median 80). FDA has posted 5 recalls for GNC devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3550 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GNC clearance
Top GNC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sa Scientific, Inc. | 49 | 1996-02-13 |
| Lee Laboratories, Inc. | 8 | 1997-08-25 |
| Immunostics Co., Inc. | 1 | 1988-09-28 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1980-08-27 |
| Volu Sol Medical Industries | 1 | 1979-09-24 |
Most recent GNC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972386 | Lee Laboratories, Inc. | VISTA ANTIGEN SALMONELLA O GROUP B | 1997-08-25 | 60 |
| K972388 | Lee Laboratories, Inc. | VISTA ANTIGEN SALMONELLA O GROUP C | 1997-08-25 | 60 |
| K972395 | Lee Laboratories, Inc. | VISTA ANTIGEN SALMONELLA O GROUP D | 1997-08-25 | 60 |
| K972392 | Lee Laboratories, Inc. | VISTA ANTIGEN SALMONELLA H A | 1997-08-25 | 60 |
| K972391 | Lee Laboratories, Inc. | VISTA ANTIGEN SALMONELLA H B | 1997-08-25 | 60 |
Recalls for GNC devices
5 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-05-19.
Frequently asked questions
What is FDA product code GNC?
GNC is the FDA product code for antigens, febrile, slide and tube, all groups, salmonella spp.. It is a Class II device, regulated under 21 CFR 866.3550 and reviewed by the Microbiology panel.
What device class is GNC?
Class II, regulation 21 CFR 866.3550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNC?
Across 60 cleared submissions the average was 76 days from receipt to decision (median 80).
Which companies have the most GNC clearances?
Sa Scientific, Inc. (49); Lee Laboratories, Inc. (8); Immunostics Co., Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Volu Sol Medical Industries (1).
Have GNC devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2010-05-19.
Next steps
- Run an FDA pathway report with predicate devices for product code GNC
- Run a recall and safety report across every GNC manufacturer
- Watch product code GNC 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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