Synalon Roller Bottle

FDA 510(k) K791049 · Dynatech Laboratories, Inc.

Substantially Equivalent

510(k) numberK791049

Submission

Device name
Synalon Roller Bottle
Applicant
Dynatech Laboratories, Inc.
Mchenry, IL, US
Received
June 6, 1979
Decision date
June 28, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KJC – Bottle, Roller, Tissue Culture
Device class
Class I (low risk)
Regulation
21 CFR 864.2240
Specialty
Hematology

Other 510(k)s with product code KJC

510(k)DeviceApplicantDecision
K880509Multisurface Roller Bottle (M.S.R.B.)KJC · Traditional Motil Plastics , Ltd.04/01/1988SE
K873137In Vitro 2.5X Roller BottleKJC · Traditional In Vitro Scientific Products08/24/1987SE

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Questions and answers

When was Synalon Roller Bottle cleared by the FDA?

Synalon Roller Bottle (K791049) received a 510(k) decision of Substantially Equivalent on June 28, 1979, 22 days after the submission was received.

What is the product code of K791049?

The FDA product code is KJC – Bottle, Roller, Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.