FDA product code CKC: Vanillin Pyruvate, Alt/Sgpt
CKC is the FDA product code for vanillin pyruvate, alt/sgpt. It is a Class I device, regulated under 21 CFR 862.1030 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under CKC, from 2 different applicants. The average 510(k) review took 45 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Vanillin Pyruvate, Alt/Sgpt |
| Device class | Class I |
| Regulation | 21 CFR 862.1030 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CKC clearance
Top CKC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 1 | 1983-10-14 |
| Gamma Enterprises, Inc. | 1 | 1978-05-03 |
Most recent CKC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832791 | Miles Laboratories, Inc. | SERAYZER ALT/SGPT REAGENT STRIPS | 1983-10-14 | 56 |
| K780507 | Gamma Enterprises, Inc. | SERUM GLUTAMIC-PYRUVIC TRANSAMINASE | 1978-05-03 | 34 |
Recalls for CKC devices
openFDA lists no recalls for product code CKC.
Frequently asked questions
What is FDA product code CKC?
CKC is the FDA product code for vanillin pyruvate, alt/sgpt. It is a Class I device, regulated under 21 CFR 862.1030 and reviewed by the Clinical Chemistry panel.
What device class is CKC?
Class I, regulation 21 CFR 862.1030. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CKC?
Across 2 cleared submissions the average was 45 days from receipt to decision (median 45).
Which companies have the most CKC clearances?
Miles Laboratories, Inc. (1); Gamma Enterprises, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CKC
- Run a recall and safety report across every CKC manufacturer
- Watch product code CKC 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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