Vacushield TM

FDA 510(k) K813159 · Gelman Sciences, Inc.

Substantially Equivalent

510(k) numberK813159

Submission

Device name
Vacushield TM
Applicant
Gelman Sciences, Inc.
Mchenry, IL, US
Received
November 16, 1981
Decision date
December 8, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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)DeviceApplicantDecision
K822121Acro PackJRL · Traditional Gelman Sciences, Inc.08/05/1982SE
K820455Centrifree Micropartition SystemJRL · Traditional Amicon, Inc.03/15/1982SE
K820224Emit Freelevel System IJRL · Traditional Syva Co.02/23/1982SE
K812750Il 703, Stat SeparatorJRL · Traditional Instrumentation Laboratory CO01/26/1982SE
K810829AcrodiscJRL · Traditional Gelman Sciences, Inc.04/08/1981SE
K801500Ultrafree Calcium FilterJRL · Traditional Millipore Corp.08/20/1980SE
K790445Ultra-FreeJRL · Traditional Millipore Corp.06/28/1979SE
K781043Cea-Immersible SeparatorJRL · Traditional Millipore Corp.09/15/1978SE

More from Millipore Corp.

510(k)DeviceDecision
K946190Drug Dispensing SpikeFMF · Traditional 03/17/1995SE
K943127Pharmassure Large Volume Transfer FiltersFPB · Traditional 09/29/1994SE
K941589Syringe Filter DevicesFMF · Traditional 09/06/1994SE
K941020Drug Reconstitution Filter DeviceFMF · Traditional 08/10/1994SE
K942275Vial Vent FilterFPB · Traditional 07/26/1994SE
K941032UnknownFMF · Traditional 05/27/1994SE
K910821Transducer ProtectorFIB · Traditional 08/12/1991SE
K892387Modified Gelman Arterial FilterDTM · Traditional 06/22/1989SE
K884176Chromatography KitDPA · Traditional 04/04/1989SE
K884178Drug Control SetDIF · Traditional 02/17/1989SE

Questions and answers

When was Vacushield TM cleared by the FDA?

Vacushield TM (K813159) received a 510(k) decision of Substantially Equivalent on December 8, 1981, 22 days after the submission was received.

What is the product code of K813159?

The FDA product code is JRL – Unit, Filter, Membrane, a Class I (low risk) device regulated under 21 CFR 862.2050.