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510(k) K884731

LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ by Amdev, Inc. — Product Code JFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1989
Date Received
November 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Amdev, Inc.

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  • K863521 — LYTENING 2 (November 5, 1986)
  • K853832 — LYTENING 1 (October 4, 1985)

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