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510(k) K002156

APPRAISE URINE MICROALBUMIN COLLECTION KIT by Osborn Group, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2000
Date Received
July 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Osborn Group, Inc.

  • K993787 — APPRAISE-CARDIO SAMPLE COLLECTION KIT (April 14, 2000)
  • K990899 — HEMOCHEK-A1C SAMPLE COLLECTION KIT (December 21, 1999)
  • K991800 — HEMOCHEK URINE COLLECTION KIT (September 24, 1999)

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