Cleared Traditional

PLATELET EXTRACT REAGENT

K873382 · Bio/Data Corp. · Hematology
Nov 1987
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K873382 is an FDA 510(k) clearance for the PLATELET EXTRACT REAGENT, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on November 20, 1987, 88 days after receiving the submission on August 24, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K873382 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1987
Decision Date November 20, 1987
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

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