JMA · Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Clinical Chemistry · 21 CFR 862.1095 · Class 1
Overview
| Product Code | JMA |
|---|---|
| Device Name | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) |
| Regulation | 21 CFR 862.1095 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K931523 | QUANTIMETRIX C-CLEAR(TM) | Quantimetrix Corp. | Jun 25, 1993 | SESE |
| K830978 | HELENA BIOSTRIP A | Helena Laboratories | May 13, 1983 | SESE |
| K822709 | URITEST 9, INLAB REAGENT STRIPS URINALY | Laprol Scientific, Inc. | Jan 28, 1983 | SESE |
Top Applicants
- Helena Laboratories — 1 clearance
- Laprol Scientific, Inc. — 1 clearance
- Quantimetrix Corp. — 1 clearance
