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510(k) K955719

SICKLE-2000 by Medicus Technologies, Inc. — Product Code GIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1996
Date Received
December 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin S
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

Other clearances for product code GIQ

  • K942276 — QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (January 20, 1995)
  • K874429 — HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 (February 4, 1988)