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510(k) K821956

HAEM-C PLUS BLOOD REFERENCE CONTROLS by Baker Instructions Corp. — Product Code JCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1982
Date Received
June 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Cell Counter, Normal And Abnormal
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

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  • K811694 — CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT (July 1, 1981)

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