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510(k) K881242

CELL-DYN RAPID-LYSE AND HEMOGLOBLIN by Abbott Diagnostics — Product Code GJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1988
Date Received
March 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cyanomethemoglobin Reagent And Standard Solution
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

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Other clearances for product code GJZ

  • K883683 — HEMOGLOBIN (October 6, 1988)