CEDIA PROCAINAMIDE ASSAY— 510(k) K962099

Name: FDA 510(k) clearance K962099
Creator: U.S. Food and Drug Administration
Published: 1996-08-27

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K962099 for CEDIA PROCAINAMIDE ASSAY, Substantially Equivalent on 1996-08-27. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code LAR
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1996-05-29
Decision date: 1996-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, 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 Boehringer Mannheim Corp.

view all

K984326 — ELECYS IGE ASSAY1999-02-08
K983047 — ACCU-CHEK HQ SYSTEM1999-02-05
K984419 — ELECSYS IGE CALCHECK1999-02-02
K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR1999-01-20
K984372 — ELECSYS CALCHECK TROPONIN T1998-12-14

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