Acro Pack
FDA 510(k) K822121 · Gelman Sciences, Inc.
510(k) numberK822121
Submission
- Device name
- Acro Pack
- Applicant
- Gelman Sciences, Inc.
Mchenry, IL, US - Received
- July 19, 1982
- Decision date
- August 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JRL – Unit, Filter, Membrane
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K820455 | Centrifree Micropartition SystemJRL · Traditional | Amicon, Inc. | 03/15/1982SE |
| K820224 | Emit Freelevel System IJRL · Traditional | Syva Co. | 02/23/1982SE |
| K812750 | Il 703, Stat SeparatorJRL · Traditional | Instrumentation Laboratory CO | 01/26/1982SE |
| K813159 | Vacushield TMJRL · Traditional | Gelman Sciences, Inc. | 12/08/1981SE |
| K810829 | AcrodiscJRL · Traditional | Gelman Sciences, Inc. | 04/08/1981SE |
| K801500 | Ultrafree Calcium FilterJRL · Traditional | Millipore Corp. | 08/20/1980SE |
| K790445 | Ultra-FreeJRL · Traditional | Millipore Corp. | 06/28/1979SE |
| K781043 | Cea-Immersible SeparatorJRL · Traditional | Millipore Corp. | 09/15/1978SE |
More from Millipore Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K946190 | Drug Dispensing SpikeFMF · Traditional | 03/17/1995SE |
| K943127 | Pharmassure Large Volume Transfer FiltersFPB · Traditional | 09/29/1994SE |
| K941589 | Syringe Filter DevicesFMF · Traditional | 09/06/1994SE |
| K941020 | Drug Reconstitution Filter DeviceFMF · Traditional | 08/10/1994SE |
| K942275 | Vial Vent FilterFPB · Traditional | 07/26/1994SE |
| K941032 | UnknownFMF · Traditional | 05/27/1994SE |
| K910821 | Transducer ProtectorFIB · Traditional | 08/12/1991SE |
| K892387 | Modified Gelman Arterial FilterDTM · Traditional | 06/22/1989SE |
| K884176 | Chromatography KitDPA · Traditional | 04/04/1989SE |
| K884178 | Drug Control SetDIF · Traditional | 02/17/1989SE |
Questions and answers
When was Acro Pack cleared by the FDA?
Acro Pack (K822121) received a 510(k) decision of Substantially Equivalent on August 5, 1982, 17 days after the submission was received.
What is the product code of K822121?
The FDA product code is JRL – Unit, Filter, Membrane, a Class I (low risk) device regulated under 21 CFR 862.2050.