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FDA 510(k)

PRECEPT NETILMICIN 32-13

K-Number: K853687 · 1985-09-13

ApplicantAustin Biological Laboratories
Decision Date1985-09-13
Product CodeLTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PRECEPT NETILMICIN 32-13 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 1985-09-13 under 510(k) number K853687. 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 NETILMICIN 32-13?

PRECEPT NETILMICIN 32-13 is a medical device that received FDA 510(k) clearance on 1985-09-13. The listed applicant is Austin Biological Laboratories. The 510(k) number is K853687.

When did PRECEPT NETILMICIN 32-13 receive FDA 510(k) clearance?

PRECEPT NETILMICIN 32-13 received FDA 510(k) clearance on 1985-09-13, under 510(k) number K853687.

Who is the listed applicant for PRECEPT NETILMICIN 32-13?

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 NETILMICIN 32-13?

The FDA product code for PRECEPT NETILMICIN 32-13 is LTW.

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Other records listing Austin Biological Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K880511XACT NEISSERIAK874727PRECEPT(TM) CIPROFLOXACINK870769AUSTIN NONFERMENTER KITK864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACIDK862446PRECEPT CEFTAZIDIMEK862560PRECEPT CEFTIZOXIME

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Related Devices (Code: LTW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K852613MIC-CONCEPT SYSTEMMicrotech Medical Systems, Inc.K853596PRECEPT CEFOPERAZONEAustin Biological LaboratoriesK853685PRECEPT TM CARBENICILLINAustin Biological LaboratoriesK853772PRECEPT METHICILLINAustin Biological LaboratoriesK853273PRECEPT CEFTRIAXONEAustin Biological LaboratoriesK853684PRECEPT 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.

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