Unit, Filter, Membrane
The Unit, Filter, Membrane is a clinical laboratory filtration device used to separate particles, cells, or macromolecules from liquid specimens or reagents by passage through a semipermeable membrane, used in specimen preparation and reagent purification for clinical chemistry and microbiology testing. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JRL and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- JRL
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K822121 | ACRO PACK | Aug 05, 1982 | Substantially Equivalent | Gelman Sciences, Inc. |
| K820455 | CENTRIFREE MICROPARTITION SYSTEM | Mar 15, 1982 | Substantially Equivalent | Amicon, Inc. |
| K820224 | EMIT FREELEVEL SYSTEM I | Feb 23, 1982 | Substantially Equivalent | Syva Co. |
| K812750 | IL 703, STAT SEPARATOR | Jan 26, 1982 | Substantially Equivalent | Instrumentation Laboratory CO |
| K813159 | VACUSHIELD TM | Dec 08, 1981 | Substantially Equivalent | Gelman Sciences, Inc. |
| K810829 | ACRODISC | Apr 08, 1981 | Substantially Equivalent | Gelman Sciences, Inc. |
| K801500 | ULTRAFREE CALCIUM FILTER | Aug 20, 1980 | Substantially Equivalent | Millipore Corp. |
| K790445 | ULTRA-FREE | Jun 28, 1979 | Substantially Equivalent | Millipore Corp. |
| K781043 | CEA-IMMERSIBLE SEPARATOR | Sep 15, 1978 | Substantially Equivalent | Millipore Corp. |
FEI Numbers
This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.