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FDA 510(k)

PHADEBACT CSF TEST

K-Number: K844999 · 1985-10-17

ApplicantPharmacia, Inc.
Decision Date1985-10-17
Product CodeGTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHADEBACT CSF 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 1985-10-17 under 510(k) number K844999. The device is classified under product code GTJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHADEBACT CSF TEST?

PHADEBACT CSF TEST is a medical device that received FDA 510(k) clearance on 1985-10-17. The listed applicant is Pharmacia, Inc.. The 510(k) number is K844999.

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

PHADEBACT CSF TEST received FDA 510(k) clearance on 1985-10-17, under 510(k) number K844999.

Who is the listed applicant for PHADEBACT CSF 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 PHADEBACT CSF TEST?

The FDA product code for PHADEBACT CSF TEST is GTJ.

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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: GTJ)

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.

K952791DIRECTIGEN MENINGITIS COMBO TESTBd Becton Dickinson Vacutainer Systems PreanalyticK915330DIRECTIGEN MENINGITIS COMBO TEST KITBd Becton Dickinson Vacutainer Systems PreanalyticK910210SLIDEX MENINGITE-KIT 5Vitek Systems, Inc.K885004BACTIGEN(R) N. MENINGITIDISArmkel, LLCK870089IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KITMicroscan Div. Baxter Healthcare Corp.K854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24Wellcome Diagnostics

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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