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510(k) K973189

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

K973189 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "RETINOL BINDING PROTEIN RBP RID KIT". The FDA issued a decision of Substantially Equivalent on September 29, 1997. The device falls under product code CZS (Retinol-Binding Protein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5765. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1997
Date Received
August 25, 1997
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

Other clearances by The Binding Site, Ltd.

  • K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (January 24, 2024)
  • K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA (March 18, 2014)
  • K132555 — HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (December 20, 2013)
  • K103824 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS (February 27, 2012)
  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MOD (December 30, 2009)
  • K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS (December 28, 2009)
  • K083289 — HUMAN BETA-2 MICROGLOBULIN KIT (May 6, 2009)
  • K082129 — HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (February 10, 2009)
  • K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (December 19, 2008)

Other clearances for product code CZS

  • K955881 — RETINOL BINDING RID KIT (March 22, 1996)
  • K853261 — LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) (August 22, 1985)

FDA data resources