JRL · Unit, Filter, Membrane
Clinical Chemistry · 21 CFR 862.2050 · Class 1
Overview
| Product Code | JRL |
|---|---|
| Device Name | Unit, Filter, Membrane |
| 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K822121 | ACRO PACK | Gelman Sciences, Inc. | Aug 5, 1982 | SESE |
| K820455 | CENTRIFREE MICROPARTITION SYSTEM | Amicon, Inc. | Mar 15, 1982 | SESE |
| K820224 | EMIT FREELEVEL SYSTEM I | Syva Co. | Feb 23, 1982 | SESE |
| K812750 | IL 703, STAT SEPARATOR | Instrumentation Laboratory CO | Jan 26, 1982 | SESE |
| K813159 | VACUSHIELD TM | Gelman Sciences, Inc. | Dec 8, 1981 | SESE |
| K810829 | ACRODISC | Gelman Sciences, Inc. | Apr 8, 1981 | SESE |
| K801500 | ULTRAFREE CALCIUM FILTER | Millipore Corp. | Aug 20, 1980 | SESE |
| K790445 | ULTRA-FREE | Millipore Corp. | Jun 28, 1979 | SESE |
| K781043 | CEA-IMMERSIBLE SEPARATOR | Millipore Corp. | Sep 15, 1978 | SESE |
Top Applicants
- Gelman Sciences, Inc. — 3 clearances
- Millipore Corp. — 3 clearances
- Amicon, Inc. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Syva Co. — 1 clearance
