FDA 510(k)

REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN

K-Number: K972359 · 1997-08-28

Decision Date1997-08-28

Product CodeJSO

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Remel, L.P.. It received FDA 510(k) clearance on 1997-08-28 under 510(k) number K972359. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN?

REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN is a medical device that received FDA 510(k) clearance on 1997-08-28. The listed applicant is Remel, L.P.. The 510(k) number is K972359.

When did REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN receive FDA 510(k) clearance?

REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN received FDA 510(k) clearance on 1997-08-28, under 510(k) number K972359.

Who is the listed applicant for REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN?

The FDA 510(k) record lists Remel, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN?

The FDA product code for REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN is JSO.

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Related Devices (Code: JSO)

K190553HardyCHROM CREHardy Diagnostics K181092CHROMID CARBA agar (CARB)Biomerieux S.A.K171061MRSASelect IIBio-Rad K162620Remel Spectra ESBLRemel, Inc.K160512HardyCHROM ESBLHardy Diagnostics K162076chromID MRSAbioMerieux, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.