JRA · Microtitrator, For Clinical Use
Clinical Chemistry · 21 CFR 862.2680 · Class 1
Overview
| Product Code | JRA |
|---|---|
| Device Name | Microtitrator, For Clinical Use |
| Regulation | 21 CFR 862.2680 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A microtitrator for clinical use is a device intended for use in micronanalysis to measure the concentration of a substance by reacting it with a measure “micro” volume of a known standardized solution.
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963268 | GENESIS RMP | Tecan U.S., Inc. | Mar 18, 1997 | SESE |
Top Applicants
- Tecan U.S., Inc. — 1 clearance
