Corning Disposal Sterile Filter System-Nylon

FDA 510(k) K844671 · Corning Medical & Scientific

Substantially Equivalent

510(k) numberK844671

Submission

Device name
Corning Disposal Sterile Filter System-Nylon
Applicant
Corning Medical & Scientific
Medfield, MA, US
Received
November 30, 1984
Decision date
February 25, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KET – Filters, Cell Collection, Tissue Processing
Device class
Class I (low risk)
Regulation
21 CFR 864.3010
Specialty
Pathology

Other 510(k)s with product code KET

510(k)DeviceApplicantDecision
K875122Disposable Sterile Syringe FiltersKET · Traditional Corning Medical & Scientific01/12/1988SE
K870196Pcte Microporous Membrane FilterKET · Traditional Poretics Corp.05/12/1987SE
K840556Disposable Syringe FiltersKET · Traditional Corning Medical & Scientific03/05/1984SE
K792633Sterilization Process/OuterwrapKET · Traditional Procter & Gamble Mfg. Co.01/11/1980SE

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K851329Magic Monoclonal Antibody Tsh(Mab Tsh)RadioimmunoaJLW · Traditional 06/13/1985SE
K850806Corning Blood Collection Capillary TubesGIO · Traditional 03/25/1985SE
K850617Corning 780 Fluorometer/DensitometerJQT · Traditional 03/12/1985SE

Questions and answers

When was Corning Disposal Sterile Filter System-Nylon cleared by the FDA?

Corning Disposal Sterile Filter System-Nylon (K844671) received a 510(k) decision of Substantially Equivalent on February 25, 1985, 87 days after the submission was received.

What is the product code of K844671?

The FDA product code is KET – Filters, Cell Collection, Tissue Processing, a Class I (low risk) device regulated under 21 CFR 864.3010.