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FDA 510(k)

PHADEBACT CSF POSITIVE CONTROLS

K-Number: K840048 · 1984-03-02

ApplicantPharmacia, Inc.
Decision Date1984-03-02
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHADEBACT CSF 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 1984-03-02 under 510(k) number K840048. 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 CSF POSITIVE CONTROLS?

PHADEBACT CSF POSITIVE CONTROLS is a medical device that received FDA 510(k) clearance on 1984-03-02. The listed applicant is Pharmacia, Inc.. The 510(k) number is K840048.

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

PHADEBACT CSF POSITIVE CONTROLS received FDA 510(k) clearance on 1984-03-02, under 510(k) number K840048.

Who is the listed applicant for PHADEBACT CSF 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 CSF POSITIVE CONTROLS?

The FDA product code for PHADEBACT CSF POSITIVE CONTROLS 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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