FDA product code GTC: Antisera, All Types, Klebsiella Spp.
GTC is the FDA product code for antisera, all types, klebsiella spp.. It is a Class I device, regulated under 21 CFR 866.3340 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GTC. The average 510(k) review took 63 days (median 63).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, All Types, Klebsiella Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3340 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GTC clearance
Top GTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ritmed, Inc. | 1 | 1983-03-29 |
Most recent GTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830276 | Ritmed, Inc. | SECURET DRAPE & INSTRUMENT RETAINER/INCL | 1983-03-29 | 63 |
Recalls for GTC devices
openFDA lists no recalls for product code GTC.
Frequently asked questions
What is FDA product code GTC?
GTC is the FDA product code for antisera, all types, klebsiella spp.. It is a Class I device, regulated under 21 CFR 866.3340 and reviewed by the Microbiology panel.
What device class is GTC?
Class I, regulation 21 CFR 866.3340. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GTC?
Across 1 cleared submissions the average was 63 days from receipt to decision (median 63).
Which companies have the most GTC clearances?
Ritmed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GTC
- Run a recall and safety report across every GTC manufacturer
- Watch product code GTC 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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