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FDA 510(k)

MERITEC-STREP GROUP A BETA-HEMOLYTIC

K-Number: K831599 · 1983-08-11

ApplicantMeridian Diagnostics, Inc.
Decision Date1983-08-11
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MERITEC-STREP GROUP A BETA-HEMOLYTIC is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K831599. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERITEC-STREP GROUP A BETA-HEMOLYTIC?

MERITEC-STREP GROUP A BETA-HEMOLYTIC is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K831599.

When did MERITEC-STREP GROUP A BETA-HEMOLYTIC receive FDA 510(k) clearance?

MERITEC-STREP GROUP A BETA-HEMOLYTIC received FDA 510(k) clearance on 1983-08-11, under 510(k) number K831599.

Who is the listed applicant for MERITEC-STREP GROUP A BETA-HEMOLYTIC?

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

What is the FDA product code for MERITEC-STREP GROUP A BETA-HEMOLYTIC?

The FDA product code for MERITEC-STREP GROUP A BETA-HEMOLYTIC is GTY.

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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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