ACTIVATED PARTIAL THROMBOPLASTIN TIME— 510(k) K915463

Name: FDA 510(k) clearance K915463
Creator: U.S. Food and Drug Administration
Published: 1992-01-23

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K915463 for ACTIVATED PARTIAL THROMBOPLASTIN TIME, Substantially Equivalent on 1992-01-23. Applicant: Sigma Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1991-12-04
Decision date: 1992-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGW

view all

K260551 — HemosIL Factor V Leiden (APC Resistance V)2026-03-20
K090105 — LUPOTEK KCT2010-12-30
K083729 — HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN2009-05-08
K060284 — CRYOCHECK CLOT APCR2006-05-10
K042762 — PEFAKIT APC-R FACTOR V LEIDEN2004-12-22

More clearances from Sigma Diagnostics, Inc.

view all

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