FDA 510(k)

PRECEPT ERYTHROMYCIN

K-Number: K853053 · 1985-08-29

Decision Date1985-08-29

Product CodeLTW

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

PRECEPT ERYTHROMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Austin Biological Laboratories. It received FDA 510(k) clearance on 1985-08-29 under 510(k) number K853053. The device is classified under product code LTW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECEPT ERYTHROMYCIN?

PRECEPT ERYTHROMYCIN is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is Austin Biological Laboratories. The 510(k) number is K853053.

When did PRECEPT ERYTHROMYCIN receive FDA 510(k) clearance?

PRECEPT ERYTHROMYCIN received FDA 510(k) clearance on 1985-08-29, under 510(k) number K853053.

Who is the listed applicant for PRECEPT ERYTHROMYCIN?

The FDA 510(k) record lists Austin Biological Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECEPT ERYTHROMYCIN?

The FDA product code for PRECEPT ERYTHROMYCIN is LTW.

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Other records listing Austin Biological Laboratories as applicant

K880511XACT NEISSERIA K874727PRECEPT(TM) CIPROFLOXACIN K870769AUSTIN NONFERMENTER KIT K864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID K862446PRECEPT CEFTAZIDIME K862560PRECEPT CEFTIZOXIME

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Related Devices (Code: LTW)

K852613MIC-CONCEPT SYSTEMMicrotech Medical Systems, Inc.K853596PRECEPT CEFOPERAZONEAustin Biological Laboratories K853685PRECEPT TM CARBENICILLINAustin Biological Laboratories K853772PRECEPT METHICILLINAustin Biological Laboratories K853273PRECEPT CEFTRIAXONEAustin Biological Laboratories K853684PRECEPT KANAMYCINAustin Biological Laboratories

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.