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510(k) K852002

CA BUFFER CA DYE by Alpkem Corp. — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
May 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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  • K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (April 11, 1986)

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