Cleared Traditional

PTT-LT TEST KIT

K941210 · American Bioproducts Co. · Hematology
Mar 1995
Decision
372d
Days
Class 2
Risk

About This 510(k) Submission

K941210 is an FDA 510(k) clearance for the PTT-LT TEST KIT, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on March 21, 1995, 372 days after receiving the submission on March 14, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K941210 FDA.gov
FDA Decision Cleared SESK
Date Received March 14, 1994
Decision Date March 21, 1995
Days to Decision 372 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGW — Test, Time, Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

Similar Devices — GGW Test, Time, Partial Thromboplastin

All 30
LUPOTEK KCT
K090105 · R2 Diagnostics, Inc. · Dec 2010
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN
K083729 · Aniara Diagnostica, LLC · May 2009
CRYOCHECK CLOT APCR
K060284 · Precision Biologic, Inc. · May 2006
PEFAKIT APC-R FACTOR V LEIDEN
K042762 · Pentapharm , Ltd. · Dec 2004
PHOSPHOLIN ES AND CALCIUM CHLORIDE
K033471 · R2 Diagnostics, Inc. · Feb 2004
GRADILEIDEN V TEST
K992456 · Gradipore , Ltd. · Dec 1999