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FDA 510(k)

MYCOAKT M. AVIUM CULTURE ID KIT

K-Number: K943049 · 1995-03-13

ApplicantDynagen, Inc.
Decision Date1995-03-13
Product CodeJSY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOAKT M. AVIUM CULTURE ID KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dynagen, Inc.. It received FDA 510(k) clearance on 1995-03-13 under 510(k) number K943049. The device is classified under product code JSY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYCOAKT M. AVIUM CULTURE ID KIT?

MYCOAKT M. AVIUM CULTURE ID KIT is a medical device that received FDA 510(k) clearance on 1995-03-13. The listed applicant is Dynagen, Inc.. The 510(k) number is K943049.

When did MYCOAKT M. AVIUM CULTURE ID KIT receive FDA 510(k) clearance?

MYCOAKT M. AVIUM CULTURE ID KIT received FDA 510(k) clearance on 1995-03-13, under 510(k) number K943049.

Who is the listed applicant for MYCOAKT M. AVIUM CULTURE ID KIT?

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

What is the FDA product code for MYCOAKT M. AVIUM CULTURE ID KIT?

The FDA product code for MYCOAKT M. AVIUM CULTURE ID KIT is JSY.

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 Dynagen, 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.

K963733NICCHECK IK943051MYCOAKT M. TUBERCULOSIS CUULTURE ID KITK943050MYCOAKT M KANSASII CULTURE ID KITK931105PROCHECK(TM) BLIND PERFORMANCE SPECIMENSK912888URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL

Related Devices (Code: JSY)

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.

K943051MYCOAKT M. TUBERCULOSIS CUULTURE ID KITDynagen, Inc.K943050MYCOAKT M KANSASII CULTURE ID KITDynagen, Inc.K880990ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTIONAlpha-Tec Systems, Inc.K830211API TB-IDENT*Analytical Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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