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FDA 510(k)

PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID

K-Number: K864069 · 1986-11-13

ApplicantAustin Biological Laboratories
Decision Date1986-11-13
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID 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 1986-11-13 under 510(k) number K864069. 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 (TM) TICARCILLIN/CLAVULANIC ACID?

PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Austin Biological Laboratories. The 510(k) number is K864069.

When did PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID receive FDA 510(k) clearance?

PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID received FDA 510(k) clearance on 1986-11-13, under 510(k) number K864069.

Who is the listed applicant for PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID?

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 (TM) TICARCILLIN/CLAVULANIC ACID?

The FDA product code for PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID 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 KITK862560PRECEPT CEFTIZOXIMEK862446PRECEPT CEFTAZIDIMEK860195PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE

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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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