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510(k) K040146

INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM by Interlab S.R.L. — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2004
Date Received
January 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Interlab S.R.L.

  • K053571 — MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOB (June 30, 2006)
  • K032862 — INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (February 3, 2004)
  • K033187 — INTERLAB IMMUNOFIXATION TEST(S) (November 19, 2003)

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