Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MYCOTRIUM-GU

K-Number: K822736 · 1982-12-03

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

Device Summary

MYCOTRIUM-GU 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 K822736. 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-GU?

MYCOTRIUM-GU 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 K822736.

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

MYCOTRIUM-GU received FDA 510(k) clearance on 1982-12-03, under 510(k) number K822736.

Who is the listed applicant for MYCOTRIUM-GU?

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-GU?

The FDA product code for MYCOTRIUM-GU is JSI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 TESTK822737MYCOTRIUM-RSK822150AMNISTAT-FLM

View all 8 devices →

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.

↑