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)

ENZYME-ASE I TUBES

K-Number: K801915 · 1980-08-20

ApplicantMicrochemical Specialities, Co.
Decision Date1980-08-20
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENZYME-ASE I TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Microchemical Specialities, Co.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801915. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYME-ASE I TUBES?

ENZYME-ASE I TUBES is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Microchemical Specialities, Co.. The 510(k) number is K801915.

When did ENZYME-ASE I TUBES receive FDA 510(k) clearance?

ENZYME-ASE I TUBES received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801915.

Who is the listed applicant for ENZYME-ASE I TUBES?

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

What is the FDA product code for ENZYME-ASE I TUBES?

The FDA product code for ENZYME-ASE I TUBES is JTO.

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 Microchemical Specialities, Co. 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.

K823198RAPID PRESUMPTIVE IDENT. GPA STREPK821992ALPHA-TOXIN DISCSK811854GALACTOSID-ASE TUBESK811853PHOLPHORYL-ASE TUBESK811852REDUCT-ASE TUBESK801916ORNITH-ASE TUBES

View all 9 devices →

Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, 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.

↑