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510(k) K896168

HEMOGLOBIN A2 MICRO COLUMN TEST by Bio-Rad — Product Code JPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1990
Date Received
October 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A2 Quantitation
Device Class
Class II
Regulation Number
864.7400
Review Panel
HE
Submission Type

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  • K875102 — DETER. OF HEMOGLOBIN A2 USING THE DIAMAT (February 24, 1988)
  • K823870 — BETA THALQUIK COLUMN #5341 (February 1, 1983)
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