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510(k) K951222

TOTAL PROTEIN (URINE) by Randox Laboratories, Ltd. — Product Code JIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1996
Date Received
March 20, 1995
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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