OPUS D-DIMER— 510(k) K972316

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K972316 for OPUS D-DIMER, Substantially Equivalent on 1997-09-09. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1997-06-20
Decision date: 1997-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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More clearances from Behring Diagnostics, Inc.

K973832 — OPUS HLH CONTROLS1997-10-27
K972929 — N ANTISERUM TO HUMAN ALBUMIN1997-10-20
K972840 — N ANTISERUM TO HUMAN TRANSFERRIN1997-10-17
K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM1997-09-12
K972116 — VON WILLEBRAND REAGENT1997-07-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.