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510(k) K871902

THE URIC ACID REAGENT SET by Macomb Biotechnology, Inc. — Product Code KNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1987
Date Received
May 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Uricase (Colorimetric)
Device Class
Class I
Regulation Number
862.1775
Review Panel
CH
Submission Type

Other clearances by Macomb Biotechnology, Inc.

  • K894951 — MODIFIED HEMOGLOBIN REAGENT SET (October 24, 1989)

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  • K993469 — WAKO L-TYPE UA F TEST (November 9, 1999)
  • K991247 — URIC ACID, MODEL UA112-01 (May 25, 1999)