JRC · Micro Pipette
Clinical Chemistry · 21 CFR 862.2050 · Class 1
Overview
| Product Code | JRC |
|---|---|
| Device Name | Micro Pipette |
| Regulation | 21 CFR 862.2050 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| GMP Exempt | Yes |
Identification
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
Classification Rationale
Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K840186 | SMI DIGITRON | Scientific Manufacturing Industries | Apr 5, 1984 | SESE |
| K834100 | PRE-CALIBRATED PIPETTES | Vitex | Feb 21, 1984 | SESE |
| K822078 | DADE DISP. DISPENSING-SPREADING PIPETS | American Dade | Jul 27, 1982 | SESE |
| K792696 | MICROPITETTE | Meridian Diagnostics, Inc. | Feb 1, 1980 | SESE |
| K770594 | LABORATORY EXPENDABLE PRODUCTS | Abco Dealers, Inc. | Jul 6, 1977 | SESE |
| K760621 | LANCER PLASTIC TRANSFER PIPETTE | Sherwood Medical Industries | Oct 5, 1976 | SESE |
Top Applicants
- Abco Dealers, Inc. — 1 clearance
- American Dade — 1 clearance
- Meridian Diagnostics, Inc. — 1 clearance
- Scientific Manufacturing Industries — 1 clearance
- Sherwood Medical Industries — 1 clearance
