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FDA 510(k)

HEXTOEN ENTERIC AGAR

K-Number: K800980 · 1980-05-23

ApplicantQuality Assurance Laboratory, Inc.
Decision Date1980-05-23
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HEXTOEN ENTERIC AGAR is the device name listed in this FDA 510(k) record. The listed applicant is Quality Assurance Laboratory, Inc.. It received FDA 510(k) clearance on 1980-05-23 under 510(k) number K800980. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEXTOEN ENTERIC AGAR?

HEXTOEN ENTERIC AGAR is a medical device that received FDA 510(k) clearance on 1980-05-23. The listed applicant is Quality Assurance Laboratory, Inc.. The 510(k) number is K800980.

When did HEXTOEN ENTERIC AGAR receive FDA 510(k) clearance?

HEXTOEN ENTERIC AGAR received FDA 510(k) clearance on 1980-05-23, under 510(k) number K800980.

Who is the listed applicant for HEXTOEN ENTERIC AGAR?

The FDA 510(k) record lists Quality Assurance Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEXTOEN ENTERIC AGAR?

The FDA product code for HEXTOEN ENTERIC AGAR is JSI.

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Other records listing Quality Assurance Laboratory, Inc. 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.

K800986TRYPTICASE SOY AGAR W5% SHEEP BLOODK800987MUELLER HINTON AGARK800978XYLOSE LYSINE DESOXYCHOLATE AGARK800981CHOCOLATE AGAR W/ENRICHMENTSK800979MUELLER HINTIN AGAR W/5% SHEEP BLOODK800983MACCONKEY AGAR

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Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK974428DIPSTREAKNovamed , Ltd.K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K890199DENTOCULT SM-STRIP MUTANSOrion Corp.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881575SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, 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.

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