PHADEBACT PNEUMOCOCCUS TEST— 510(k) K802337

Substantially Equivalent

Pharmacia, Inc.

FDA 510(k) clearance K802337 for PHADEBACT PNEUMOCOCCUS TEST, Substantially Equivalent on 1980-10-31. Applicant: Pharmacia, Inc.. Device class: 1.

Clearance details

Applicant: Pharmacia, Inc.
Product code: Code GWC
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1980-09-26
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWC

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K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE1987-03-25
K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-1101986-12-18
K842239 — VENTRESCREEN STREP A TEST1984-07-02

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K972068 — UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K821997-07-03
K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.01997-06-30
K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH1997-04-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.