FDA product code CKE: Acid Phosphatase, Thymolphthale Inmonophosphate
CKE is the FDA product code for acid phosphatase, thymolphthale inmonophosphate. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel. FDA has cleared 9 510(k) submissions under CKE, from 9 different applicants. The average 510(k) review took 66 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Acid Phosphatase, Thymolphthale Inmonophosphate |
| Device class | Class II |
| Regulation | 21 CFR 862.1020 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CKE clearance
Top CKE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 1 | 1992-03-17 |
| Tech Intl. Co. | 1 | 1992-02-27 |
| King Diagnostics, Inc. | 1 | 1988-01-27 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1986-11-28 |
| Sterling Diagnostics, Inc. | 1 | 1986-03-05 |
4 more applicants have CKE clearances. See the full list in Caduvo.
Most recent CKE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914167 | Eastman Kodak Company | CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE | 1992-03-17 | 182 |
| K915705 | Tech Intl. Co. | ACID PHOSPHATASE REAGENT SET | 1992-02-27 | 90 |
| K873726 | King Diagnostics, Inc. | ACID PHOSPHATASE TEST | 1988-01-27 | 134 |
| K864230 | E.I. Dupont DE Nemours & Co., Inc. | DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM | 1986-11-28 | 31 |
| K860476 | Sterling Diagnostics, Inc. | ACID PHOSPHATASE REAGENT SET | 1986-03-05 | 26 |
Recalls for CKE devices
openFDA lists no recalls for product code CKE.
Frequently asked questions
What is FDA product code CKE?
CKE is the FDA product code for acid phosphatase, thymolphthale inmonophosphate. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel.
What device class is CKE?
Class II, regulation 21 CFR 862.1020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CKE?
Across 9 cleared submissions the average was 66 days from receipt to decision (median 31).
Which companies have the most CKE clearances?
Eastman Kodak Company (1); Tech Intl. Co. (1); King Diagnostics, Inc. (1); E.I. Dupont DE Nemours & Co., Inc. (1); Sterling Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CKE
- Run a recall and safety report across every CKE manufacturer
- Watch product code CKE 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times