LASER ASO KIT— 510(k) K854039

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K854039 for LASER ASO KIT, Substantially Equivalent on 1985-10-28. Applicant: Behring Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1985-10-02
Decision date: 1985-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GTQ

K052645 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 68018732005-12-14
K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT1995-10-20
K915742 — TURBIQUANT ASL1993-06-28
K926236 — BECKMAN ANTI-STREPTOLYSIN O KIT1993-06-15
K924247 — ACCUTEX ASO LATEX TEST1992-12-07

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.