Susceptibility Disk, Cinoxacin 100 Mcg.

FDA 510(k) K792349 · Pfizer, Inc.

Substantially Equivalent

510(k) numberK792349

Submission

Device name
Susceptibility Disk, Cinoxacin 100 Mcg.
Applicant
Pfizer, Inc.
Mchenry, IL, US
Received
November 19, 1979
Decision date
March 12, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JNT – Chromatographic, Phospholipids
Device class
Class I (low risk)
Regulation
21 CFR 862.1575
Specialty
Clinical Chemistry

Other 510(k)s with product code JNT

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K922792ZithromaxJNT · Traditional Difco Laboratories, Inc.07/30/1992SE
K914040Phospholipid Reagent SetJNT · Traditional Sterling Diagnostics, Inc.10/30/1991SE

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Questions and answers

When was Susceptibility Disk, Cinoxacin 100 Mcg. cleared by the FDA?

Susceptibility Disk, Cinoxacin 100 Mcg. (K792349) received a 510(k) decision of Substantially Equivalent on March 12, 1980, 114 days after the submission was received.

What is the product code of K792349?

The FDA product code is JNT – Chromatographic, Phospholipids, a Class I (low risk) device regulated under 21 CFR 862.1575.