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FDA 510(k)

PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)

K-Number: K854577 · 1986-02-05

ApplicantAustin Biological Laboratories
Decision Date1986-02-05
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) 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 1986-02-05 under 510(k) number K854577. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)?

PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) is a medical device that received FDA 510(k) clearance on 1986-02-05. The listed applicant is Austin Biological Laboratories. The 510(k) number is K854577.

When did PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) receive FDA 510(k) clearance?

PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) received FDA 510(k) clearance on 1986-02-05, under 510(k) number K854577.

Who is the listed applicant for PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)?

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 AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)?

The FDA product code for PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) is JWY.

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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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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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