FDA product code CKD: Hydrazone Colorimetry, Alt/Sgpt
CKD is the FDA product code for hydrazone colorimetry, alt/sgpt. It is a Class I device, regulated under 21 CFR 862.1030 and reviewed by the Clinical Chemistry panel. FDA has cleared 11 510(k) submissions under CKD, from 11 different applicants. The average 510(k) review took 92 days (median 52). FDA has posted 2 recalls for CKD devices.
Classification
| Field | Value |
|---|---|
| Device name | Hydrazone Colorimetry, 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 CKD clearance
Top CKD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cholestech Corp. | 1 | 1999-09-09 |
| Ortho Diagnostic Systems, Inc. | 1 | 1995-05-16 |
| Roche Diagnostic Systems, Inc. | 1 | 1990-02-16 |
| Electro-Nucleonics, Inc. | 1 | 1988-12-29 |
| Tech-Co, Inc. | 1 | 1988-10-13 |
6 more applicants have CKD clearances. See the full list in Caduvo.
Most recent CKD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991834 | Cholestech Corp. | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | 1999-09-09 | 104 |
| K941192 | Ortho Diagnostic Systems, Inc. | ORTHO ALT MICROWELL TEST SYSTEM | 1995-05-16 | 428 |
| K896237 | Roche Diagnostic Systems, Inc. | COBAS READY ALT REAGENT | 1990-02-16 | 108 |
| K884784 | Electro-Nucleonics, Inc. | VIRGO(R) MICROWELL ALT ASSAY | 1988-12-29 | 44 |
| K883387 | Tech-Co, Inc. | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | 1988-10-13 | 64 |
Recalls for CKD devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-03-06.
Frequently asked questions
What is FDA product code CKD?
CKD is the FDA product code for hydrazone colorimetry, 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 CKD?
Class I, regulation 21 CFR 862.1030. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CKD?
Across 11 cleared submissions the average was 92 days from receipt to decision (median 52).
Which companies have the most CKD clearances?
Cholestech Corp. (1); Ortho Diagnostic Systems, Inc. (1); Roche Diagnostic Systems, Inc. (1); Electro-Nucleonics, Inc. (1); Tech-Co, Inc. (1).
Have CKD devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2013-03-06.
Next steps
- Run an FDA pathway report with predicate devices for product code CKD
- Run a recall and safety report across every CKD manufacturer
- Watch product code CKD 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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