Culturette Brand-Pva/Formalin Kit

FDA 510(k) K792654 · Marion Laboratories, Inc.

Substantially Equivalent

510(k) numberK792654

Submission

Device name
Culturette Brand-Pva/Formalin Kit
Applicant
Marion Laboratories, Inc.
Mchenry, IL, US
Received
December 26, 1979
Decision date
January 24, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IFQ – Formulations, Mercuric Chloride For Tissue
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code IFQ

510(k)DeviceApplicantDecision
K792714Para-Pak PvaIFQ · Traditional Meridian Diagnostics, Inc.01/24/1980SE

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Questions and answers

When was Culturette Brand-Pva/Formalin Kit cleared by the FDA?

Culturette Brand-Pva/Formalin Kit (K792654) received a 510(k) decision of Substantially Equivalent on January 24, 1980, 29 days after the submission was received.

What is the product code of K792654?

The FDA product code is IFQ – Formulations, Mercuric Chloride For Tissue, a Class I (low risk) device regulated under 21 CFR 864.4010.