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510(k) K830804

LABILE REMOVING HEMOLYZING REAGENT by Corning Medical & Scientific — Product Code JBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1983
Date Received
March 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Analysis, Electrophoretic Hemoglobin
Device Class
Class II
Regulation Number
864.7440
Review Panel
HE
Submission Type

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  • K901143 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (May 23, 1990)
  • K820518 — GELMAN GLYCO-PHORE BUFFER (April 9, 1982)
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