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FDA 510(k)

ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL

K-Number: K864752 · 1987-02-26

ApplicantAbbott Laboratories
Decision Date1987-02-26
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1987-02-26 under 510(k) number K864752. 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 ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL?

ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL is a medical device that received FDA 510(k) clearance on 1987-02-26. The listed applicant is Abbott Laboratories. The 510(k) number is K864752.

When did ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL receive FDA 510(k) clearance?

ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL received FDA 510(k) clearance on 1987-02-26, under 510(k) number K864752.

Who is the listed applicant for ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL?

The FDA product code for ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL 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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