Corning Disposable Roller Bottles

FDA 510(k) K872076 · Corning Medical & Scientific

Substantially Equivalent

510(k) numberK872076

Submission

Device name
Corning Disposable Roller Bottles
Applicant
Corning Medical & Scientific
Oneonta, NY, US
Received
May 29, 1987
Decision date
June 15, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KJB – Apparatus, Roller
Device class
Class I (low risk)
Regulation
21 CFR 864.2240
Specialty
Hematology

Other 510(k)s with product code KJB

510(k)DeviceApplicantDecision
K881466Cell-Culture ShakerKJB · Traditional Cryodyne Technologies, Inc.04/18/1988SE
K852506Bioglas Microcarrier BeadKJB · Traditional Solohill Engineering, Inc.07/12/1985SE

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Questions and answers

When was Corning Disposable Roller Bottles cleared by the FDA?

Corning Disposable Roller Bottles (K872076) received a 510(k) decision of Substantially Equivalent on June 15, 1987, 17 days after the submission was received.

What is the product code of K872076?

The FDA product code is KJB – Apparatus, Roller, a Class I (low risk) device regulated under 21 CFR 864.2240.