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510(k) K991315

MICROALBUSTIX REAGENT STRIPS (OTC) by Bayer Corp. — Product Code JIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1999
Date Received
April 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1645
Review Panel
CH
Submission Type

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Other clearances for product code JIR

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  • K061419 — TECO MICROALBUMIN 2-1 COMBO STRIPS (January 26, 2007)
  • K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (August 23, 2002)
  • K001810 — URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (August 14, 2000)
  • K994035 — IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (February 1, 2000)
  • K992257 — NEW MULTIPLES REAGENT STRIPS (November 24, 1999)
  • K983774 — UALB (January 28, 1999)
  • K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINE (October 7, 1998)