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510(k) K990664

PRIMA SYSTEM - OLD, BARTELS ELISA - NEW by Intracel Corp. — Product Code LLH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1999
Date Received
March 1, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagents, Clostridium Difficile Toxin
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
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