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FDA 510(k)

MYCOTRIUM-RS

K-Number: K822737 · 1982-12-03

ApplicantHana Biologics, Inc.
Decision Date1982-12-03
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOTRIUM-RS is the device name listed in this FDA 510(k) record. The listed applicant is Hana Biologics, Inc.. It received FDA 510(k) clearance on 1982-12-03 under 510(k) number K822737. 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 MYCOTRIUM-RS?

MYCOTRIUM-RS is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Hana Biologics, Inc.. The 510(k) number is K822737.

When did MYCOTRIUM-RS receive FDA 510(k) clearance?

MYCOTRIUM-RS received FDA 510(k) clearance on 1982-12-03, under 510(k) number K822737.

Who is the listed applicant for MYCOTRIUM-RS?

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

What is the FDA product code for MYCOTRIUM-RS?

The FDA product code for MYCOTRIUM-RS is JSI.

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Other records listing Hana Biologics, 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.

K883682CHANG MEDIUM (ADDITIONAL INDICATIONS)K855205MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEMK834616AMNIO STAT-FLM AGGLUTINATION TESTK833933ACE COLOR TESTK822736MYCOTRIUM-GUK822150AMNISTAT-FLM

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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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