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FDA 510(k)

API-CTS STREPTOCOCCUS

K-Number: K801951 · 1980-09-26

ApplicantAnalytical Products, Inc.
Decision Date1980-09-26
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

API-CTS STREPTOCOCCUS is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Products, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K801951. 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 API-CTS STREPTOCOCCUS?

API-CTS STREPTOCOCCUS is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Analytical Products, Inc.. The 510(k) number is K801951.

When did API-CTS STREPTOCOCCUS receive FDA 510(k) clearance?

API-CTS STREPTOCOCCUS received FDA 510(k) clearance on 1980-09-26, under 510(k) number K801951.

Who is the listed applicant for API-CTS STREPTOCOCCUS?

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

What is the FDA product code for API-CTS STREPTOCOCCUS?

The FDA product code for API-CTS STREPTOCOCCUS is JTO.

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Related Devices (Code: JTO)

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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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