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510(k) K990899

HEMOCHEK-A1C SAMPLE COLLECTION KIT by Osborn Group, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1999
Date Received
March 18, 1999
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 Osborn Group, Inc.

  • K002156 — APPRAISE URINE MICROALBUMIN COLLECTION KIT (December 19, 2000)
  • K993787 — APPRAISE-CARDIO SAMPLE COLLECTION KIT (April 14, 2000)
  • K991800 — HEMOCHEK URINE COLLECTION KIT (September 24, 1999)

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