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FDA 510(k)

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II

K-Number: K971522 · 1998-03-03

ApplicantAbbott Laboratories
Decision Date1998-03-03
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-03-03 under 510(k) number K971522. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II?

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II is a medical device that received FDA 510(k) clearance on 1998-03-03. The listed applicant is Abbott Laboratories. The 510(k) number is K971522.

When did ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II receive FDA 510(k) clearance?

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II received FDA 510(k) clearance on 1998-03-03, under 510(k) number K971522.

Who is the listed applicant for ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II?

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 PLUS STREP A WITH ON BOARD CONTROLS (OBC) II?

The FDA product code for ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II is GTZ.

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Related Devices (Code: GTZ)

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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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