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510(k) K831887

BACTIGEN S. PNEUMONIAE by Armkel, LLC — Product Code GWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1983
Date Received
June 13, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, Streptococcus Pneumoniae
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

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Other clearances for product code GWC

  • K884965 — BACTIGEN(R) MENINGITIDIS PANEL (February 7, 1989)
  • K884966 — BACTIGEN(R) S. PNEUMONIAE (February 7, 1989)
  • K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (March 25, 1987)
  • K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (December 18, 1986)
  • K842239 — VENTRESCREEN STREP A TEST (July 2, 1984)
  • K841376 — WELLCOGEN S. PNEUMONIAE (May 2, 1984)
  • K821960 — BBL PNEUMOSLIDE TEST (July 30, 1982)
  • K802337 — PHADEBACT PNEUMOCOCCUS TEST (October 31, 1980)