CJT · Hydrazone Colorimetry, Aldolase
Clinical Chemistry · 21 CFR 862.1040 · Class 1
Overview
| Product Code | CJT |
|---|---|
| Device Name | Hydrazone Colorimetry, Aldolase |
| Regulation | 21 CFR 862.1040 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy.
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 |
|---|---|---|---|---|
| K760821 | REAGENT SYSTEM | Sigma Chemical Co. | Oct 21, 1976 | SESE |
Top Applicants
- Sigma Chemical Co. — 1 clearance
