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510(k) K955881

RETINOL BINDING RID KIT by The Binding Site, Ltd. — Product Code CZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1996
Date Received
December 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retinol-Binding Protein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5765
Review Panel
IM
Submission Type

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Other clearances for product code CZS

  • K973189 — RETINOL BINDING PROTEIN RBP RID KIT (September 29, 1997)
  • K853261 — LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) (August 22, 1985)