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510(k) K884967

BACTIGEN(R) H. INFLUENZAE TYPE B by Armkel, LLC — Product Code GRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1989
Date Received
November 30, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, H. Influenza
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

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Other clearances for product code GRP

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  • K823348 — H. INFLUENZA B ANTISERA FOR CIE (December 28, 1982)
  • K821266 — BBL DIRECTIGEN MENINGITIS TEST KIT (June 1, 1982)
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