OPUS HLH— 510(k) K962866

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K962866 for OPUS HLH, Substantially Equivalent on 1996-08-23. Applicant: Behring Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1996-07-23
Decision date: 1996-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEP

K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE2003-01-16
K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST2002-11-05
K021409 — AT HOME OVULATION TEST, MODEL 90322002-05-24
K013874 — CLEARPLANE EASY OVULATION TEST2002-02-19
K013323 — TCI-31 LIFELONG OVULATION TESTER2001-12-05

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
K972316 — OPUS D-DIMER1997-09-09

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