Cleared Traditional

PHOSPHOLIN ES AND CALCIUM CHLORIDE

K033471 · R2 Diagnostics, Inc. · Hematology
Feb 2004
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K033471 is an FDA 510(k) clearance for the PHOSPHOLIN ES AND CALCIUM CHLORIDE, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on February 4, 2004, 93 days after receiving the submission on November 3, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K033471 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2003
Decision Date February 04, 2004
Days to Decision 93 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
GRADILEIDEN V TEST
K992456 · Gradipore , Ltd. · Dec 1999
CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
K982062 · Precision Biologicals, Inc. · Jan 1999