DNN · Calibrators, Ethyl Alcohol
Clinical Toxicology · 21 CFR 862.3200 · Class 2
Overview
| Product Code | DNN |
|---|---|
| Device Name | Calibrators, Ethyl Alcohol |
| Regulation | 21 CFR 862.3200 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
Identification
A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990516 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | Mar 31, 1999 | SESE |
| K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | Oct 1, 1997 | SESE |
| K924733 | ETHYL ALCOHOL CALIBRATORS & CONTROL | Diagnostic Reagents, Inc. | Dec 9, 1992 | SESE |
| K882117 | ETHYL ALCOHOL STANDARD | Verichem Laboratories, Inc. | Aug 4, 1988 | SESE |
| K853532 | ALCOHOL CALIBRATORS | Diagnostic Systems | Sep 16, 1985 | SESE |
| K810466 | ETHYL ALCOHOL SERUM CALIBRATOR | Syva Co. | Mar 6, 1981 | SESE |
| K802620 | EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR | Syva Co. | Oct 31, 1980 | SESE |
Top Applicants
- Emd Chemicals, Inc. — 2 clearances
- Syva Co. — 2 clearances
- Diagnostic Reagents, Inc. — 1 clearance
- Diagnostic Systems — 1 clearance
- Verichem Laboratories, Inc. — 1 clearance
