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510(k) K823756

ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 by Em Industries, Inc. — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1983
Date Received
December 14, 1982
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

Other clearances by Em Industries, Inc.

  • K832314 — CARDIZYME PLUS LD #65094/93 (September 1, 1983)

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