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510(k) K853261

LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) by Behring Diagnostics, Inc. — Product Code CZS

K853261 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)". The FDA issued a decision of Substantially Equivalent on August 22, 1985. The device falls under product code CZS (Retinol-Binding Protein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5765. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1985
Date Received
August 2, 1985
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 Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

Other clearances for product code CZS

  • K973189 — RETINOL BINDING PROTEIN RBP RID KIT (September 29, 1997)
  • K955881 — RETINOL BINDING RID KIT (March 22, 1996)

FDA data resources