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FDA 510(k)

PHADEBACT STREP POSITIVE CONTROLS

K-Number: K832248 · 1983-09-01

ApplicantPharmacia, Inc.
Decision Date1983-09-01
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHADEBACT STREP POSITIVE CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1983-09-01 under 510(k) number K832248. 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 PHADEBACT STREP POSITIVE CONTROLS?

PHADEBACT STREP POSITIVE CONTROLS is a medical device that received FDA 510(k) clearance on 1983-09-01. The listed applicant is Pharmacia, Inc.. The 510(k) number is K832248.

When did PHADEBACT STREP POSITIVE CONTROLS receive FDA 510(k) clearance?

PHADEBACT STREP POSITIVE CONTROLS received FDA 510(k) clearance on 1983-09-01, under 510(k) number K832248.

Who is the listed applicant for PHADEBACT STREP POSITIVE CONTROLS?

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

What is the FDA product code for PHADEBACT STREP POSITIVE CONTROLS?

The FDA product code for PHADEBACT STREP POSITIVE CONTROLS is GTY.

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Other records listing Pharmacia, Inc. as applicant

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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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