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510(k) K964687

N LATEX CRP MONO REAGENT by Behring Diagnostics, Inc. — Product Code DCH

K964687 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "N LATEX CRP MONO REAGENT". The FDA issued a decision of Substantially Equivalent on December 16, 1996. The device falls under product code DCH (System, Test, C-Reactive Protein, Rhodamine), a Class II device regulated under 21 CFR 866.5270. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1996
Date Received
September 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein, Rhodamine
Device Class
Class II
Regulation Number
866.5270
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)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

FDA data resources