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510(k) K870516

ALBUMIN SCREEN TEST by Sclavo, Inc. — Product Code JIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1987
Date Received
February 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (September 2, 1997)
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  • K944664 — WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR (February 7, 1995)
  • K936202 — URINARY ALBUMIN TEST PACK (May 9, 1994)
  • K935662 — SYNERMED IR 500 CHEMISTRY ANALYZER (April 26, 1994)
  • K903123 — RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT (September 14, 1990)
  • K902216 — WAKO(TM) MICRO-ALBUMIN (June 18, 1990)