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FDA 510(k)

PHADEBACT PNEUMOCOCCUS TEST

K-Number: K802337 · 1980-10-31

ApplicantPharmacia, Inc.
Decision Date1980-10-31
Product CodeGWC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PHADEBACT PNEUMOCOCCUS 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 1980-10-31 under 510(k) number K802337. The device is classified under product code GWC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHADEBACT PNEUMOCOCCUS TEST?

PHADEBACT PNEUMOCOCCUS TEST is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Pharmacia, Inc.. The 510(k) number is K802337.

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

PHADEBACT PNEUMOCOCCUS TEST received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802337.

Who is the listed applicant for PHADEBACT PNEUMOCOCCUS 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 PNEUMOCOCCUS TEST?

The FDA product code for PHADEBACT PNEUMOCOCCUS TEST is GWC.

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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: GWC)

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.

K884965BACTIGEN(R) MENINGITIDIS PANELArmkel, LLCK884966BACTIGEN(R) S. PNEUMONIAEArmkel, LLCK870029IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAEAmerican Micro ScanK862848LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110Lkb Instruments, Inc.K842239VENTRESCREEN STREP A TESTVentrex Laboratories, Inc.K841376WELLCOGEN S. PNEUMONIAEWellcome 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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