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510(k) K862848

LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 by Lkb Instruments, Inc. — Product Code GWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1986
Date Received
July 29, 1986
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

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  • K841376 — WELLCOGEN S. PNEUMONIAE (May 2, 1984)
  • K831887 — BACTIGEN S. PNEUMONIAE (September 26, 1983)
  • K821960 — BBL PNEUMOSLIDE TEST (July 30, 1982)
  • K802337 — PHADEBACT PNEUMOCOCCUS TEST (October 31, 1980)