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FDA 510(k)

RAPID PRESUMPTIVE IDENT. GPA STREP

K-Number: K823198 · 1982-11-16

ApplicantMicrochemical Specialities, Co.
Decision Date1982-11-16
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID PRESUMPTIVE IDENT. GPA STREP 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 1982-11-16 under 510(k) number K823198. 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 RAPID PRESUMPTIVE IDENT. GPA STREP?

RAPID PRESUMPTIVE IDENT. GPA STREP is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Microchemical Specialities, Co.. The 510(k) number is K823198.

When did RAPID PRESUMPTIVE IDENT. GPA STREP receive FDA 510(k) clearance?

RAPID PRESUMPTIVE IDENT. GPA STREP received FDA 510(k) clearance on 1982-11-16, under 510(k) number K823198.

Who is the listed applicant for RAPID PRESUMPTIVE IDENT. GPA STREP?

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 RAPID PRESUMPTIVE IDENT. GPA STREP?

The FDA product code for RAPID PRESUMPTIVE IDENT. GPA STREP is JTO.

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Other records listing Microchemical Specialities, Co. as applicant

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Related Devices (Code: JTO)

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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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