OPUS CARBAMAZEPINE TEST SYSTEM— 510(k) K896860

Name: FDA 510(k) clearance K896860
Creator: U.S. Food and Drug Administration
Published: 1990-01-02

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K896860 for OPUS CARBAMAZEPINE TEST SYSTEM, Substantially Equivalent on 1990-01-02. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1989-12-05
Decision date: 1990-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLT

view all

K151578 — Carbamazepine Gen 42015-10-22
K123518 — ABBOTT CARBAMAZEPINE ASSAY2013-06-05
K103627 — ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS2011-10-14
K063131 — CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS2007-10-05
K042808 — ADVIA IMS CARBAMAZEPINE METHOD2005-02-08

More clearances from Pb Diagnostic Systems, Inc.

view all

K940507 — OPUS FT4 TEST SYSTEM1994-07-28
K934762 — OPUS PROCAINAMIDE TEST SYSTEM1994-07-20
K933389 — OPUS CMV-G1994-06-28
K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION1994-03-07
K935229 — OPUS DIGITOXIN1993-12-22

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