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510(k) K780819

GLYCOHEMOGLOBIN-SKREEN TEST KIT by Eppendorf-Brinkmann, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1978
Date Received
May 17, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

Other clearances by Eppendorf-Brinkmann, Inc.

  • K772337 — URINARY 17-KETOSTERIOD/17 (January 12, 1978)
  • K772151 — URINARY VMA - SCREEN TEST KIT (November 30, 1977)
  • K761271 — URIN. L7-OH CORTICOSTEROID T(NON HYDRO) (February 14, 1977)

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