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FDA 510(k)

PHADIRECT STREP A TEST

K-Number: K854150 · 1985-10-23

ApplicantPharmacia, Inc.
Decision Date1985-10-23
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHADIRECT STREP A TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1985-10-23 under 510(k) number K854150. 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 PHADIRECT STREP A TEST?

PHADIRECT STREP A TEST is a medical device that received FDA 510(k) clearance on 1985-10-23. The listed applicant is Pharmacia, Inc.. The 510(k) number is K854150.

When did PHADIRECT STREP A TEST receive FDA 510(k) clearance?

PHADIRECT STREP A TEST received FDA 510(k) clearance on 1985-10-23, under 510(k) number K854150.

Who is the listed applicant for PHADIRECT STREP A TEST?

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 PHADIRECT STREP A TEST?

The FDA product code for PHADIRECT STREP A TEST is GTZ.

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Other records listing Pharmacia, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974350ALLERGAN IMMUNO CAP M4, M8, K70K972364UNICAP PHADIATOPK972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHK962274UNICAP 100

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Related Devices (Code: GTZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K011709UNI-GOLD STREP A TEST KITTrinity Biotech, PlcK010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962060STREP A OIA MAXBiostar, Inc.

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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