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510(k) K812365

PARA 1 SENDAI HEMAGGLUTININ by Dutchland Laboratories, Inc. — Product Code GQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1981
Date Received
August 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4
Device Class
Class I
Regulation Number
866.3400
Review Panel
MI
Submission Type

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  • K821918 — POWDERED RPMI-1603 MEDIUM (July 27, 1982)
  • K821917 — WAYMOUTH'S POWDER MEDIUM (July 27, 1982)
  • K821914 — COON'S F-12 POWDER MEDIUM (July 27, 1982)
  • K821919 — POWDERED RPMI-1634 MEDIUM (July 27, 1982)
  • K821916 — IMPROVED MEM-RICHTER'S POWDER MODIF. (July 27, 1982)
  • K820919 — EARLE'S-199 POWDERED MEDIUM (April 21, 1982)