KLJ · Nad Reduction (U.V.), Phosphohexose Isomerase
Clinical Chemistry · 21 CFR 862.1570 · Class 1
Overview
| Product Code | KLJ |
|---|---|
| Device Name | Nad Reduction (U.V.), Phosphohexose Isomerase |
| Regulation | 21 CFR 862.1570 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A phosphohexose isomerase test system is a device intended to measure the activity of the enzyme phosphohexose isomerase in serum. Measurements of phosphohexose isomerase are used in the diagnosis and treatment of muscle diseases such as muscular dystrophy, liver diseases such as hepatitis or cirrhosis, and metastatic carcinoma.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K770577 | DETER. OF PHOSPHOHEXOSE ISOMERASE | Sigma Chemical Co. | Jun 17, 1977 | SESE |
Top Applicants
- Sigma Chemical Co. — 1 clearance
