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FDA 510(k)

PHOLPHORYL-ASE TUBES

K-Number: K811853 · 1981-07-16

ApplicantMicrochemical Specialities, Co.
Decision Date1981-07-16
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHOLPHORYL-ASE 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 1981-07-16 under 510(k) number K811853. 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 PHOLPHORYL-ASE TUBES?

PHOLPHORYL-ASE TUBES is a medical device that received FDA 510(k) clearance on 1981-07-16. The listed applicant is Microchemical Specialities, Co.. The 510(k) number is K811853.

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

PHOLPHORYL-ASE TUBES received FDA 510(k) clearance on 1981-07-16, under 510(k) number K811853.

Who is the listed applicant for PHOLPHORYL-ASE 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 PHOLPHORYL-ASE TUBES?

The FDA product code for PHOLPHORYL-ASE TUBES is JTO.

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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 TUBESK811852REDUCT-ASE TUBESK801915ENZYME-ASE I TUBESK801916ORNITH-ASE TUBES

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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.

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