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510(k) K911347

LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL by Bio-Rad — Product Code JCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1991
Date Received
March 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K913427 — SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (November 19, 1991)
  • K910431 — HEMOCARD CONTROL (March 11, 1991)
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