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FDA 510(k)

ALPHA-TOXIN DISCS

K-Number: K821992 · 1982-10-18

ApplicantMicrochemical Specialities, Co.
Decision Date1982-10-18
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ALPHA-TOXIN DISCS 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 1982-10-18 under 510(k) number K821992. 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 ALPHA-TOXIN DISCS?

ALPHA-TOXIN DISCS is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Microchemical Specialities, Co.. The 510(k) number is K821992.

When did ALPHA-TOXIN DISCS receive FDA 510(k) clearance?

ALPHA-TOXIN DISCS received FDA 510(k) clearance on 1982-10-18, under 510(k) number K821992.

Who is the listed applicant for ALPHA-TOXIN DISCS?

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 ALPHA-TOXIN DISCS?

The FDA product code for ALPHA-TOXIN DISCS 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 STREPK811853PHOLPHORYL-ASE TUBESK811854GALACTOSID-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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