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FDA 510(k)

HEKTOEN ENTERIC AGAR

K-Number: K841129 · 1984-03-23

ApplicantAnaerobe Systems
Decision Date1984-03-23
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HEKTOEN ENTERIC AGAR is the device name listed in this FDA 510(k) record. The listed applicant is Anaerobe Systems. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K841129. 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 HEKTOEN ENTERIC AGAR?

HEKTOEN ENTERIC AGAR is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Anaerobe Systems. The 510(k) number is K841129.

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

HEKTOEN ENTERIC AGAR received FDA 510(k) clearance on 1984-03-23, under 510(k) number K841129.

Who is the listed applicant for HEKTOEN ENTERIC AGAR?

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

What is the FDA product code for HEKTOEN ENTERIC AGAR?

The FDA product code for HEKTOEN ENTERIC AGAR is JSI.

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Other records listing Anaerobe Systems 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.

K844381COLISTIN 10 MCG. DIFFERENTIAL DISKK844382VANCOMYCIN 5MCG DIFFERENTIAL DISKK844383KANAMYCIN 1000 MCG DIFFERENTIAL DISKK844380BILE DIFFERENTIAL DISKK841303CAMPYLOBACTER THIOGLYCOLLATE MEDK841142LEVINE EOSIN METHYLENE BLUE 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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