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510(k) K970921

STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) by Alko Diagnostic Corp. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1997
Date Received
March 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K950902 — ALKO TONOMETERED SALINE CONTROL (March 30, 1995)
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