OPUS PROCAINAMIDE TEST SYSTEM— 510(k) K934762

Name: FDA 510(k) clearance K934762
Creator: U.S. Food and Drug Administration
Published: 1994-07-20

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K934762 for OPUS PROCAINAMIDE TEST SYSTEM, Substantially Equivalent on 1994-07-20. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code LAR
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1993-10-04
Decision date: 1994-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LAR

view all

K060773 — ONLINE TDM PROCAINAMIDE2006-08-23
K032573 — DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF1102003-10-31
K010812 — EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K2292001-04-13
K971716 — PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM1997-06-27
K963306 — CEDIA N-ACETYLPROCAINAMIDE ASSAY1996-10-29

More clearances from Pb Diagnostic Systems, Inc.

view all

K940507 — OPUS FT4 TEST SYSTEM1994-07-28
K933389 — OPUS CMV-G1994-06-28
K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION1994-03-07
K935229 — OPUS DIGITOXIN1993-12-22
K934705 — OPUS NAPA1993-11-22

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