ClearanceBrief
Panels › Hematology › Product code GGN · Class 2

Plasma, Coagulation Control

Regulation 864.5425

0510(k)s in 12 months (99 all time)
2recalls in 12 months (16 all time)
15recalls that name a 510(k)
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Top companies in GGN

Company510(k)sRecalls
Instrumentation Laboratory83
International Technidyne Corp.44
Bio-Rad70
Helena Laboratories70
Precision Biologicals, Inc.60
American Bioproducts Co.50
Aniara Diagnostica LLC05
Cardiovascular Diagnostics, Inc.50
Diagnostica Stago, Inc.32
Pacific Hemostasis50
DateFirm and productCodeLinked 510(k)
Aug 5, 2026Aniara Diagnostica LLC
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Open, Classified		 GGNNone listed
Jun 16, 2026Accriva Diagnostics, Inc.
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Open, Classified		 GGNK202101
Jun 28, 2022Aniara Diagnostica LLC
BIOPHEN UFH Control Plasma
Terminated		 GGNK051472
Dec 23, 2019Diagnostica Stago, Inc.
STA SYSTEM CONROL N + P (ref. 00678)
Terminated		 GGNK943518
Mar 19, 2019Aniara Diagnostica LLC
BIOPHEN LMWH Control C4, REF 224201
Terminated		 GGNK051472
Mar 19, 2019Aniara Diagnostica LLC
BIOPHEN UFH Control C1, REF 224101
Terminated		 GGNK051472
Mar 19, 2019Aniara Diagnostica LLC
BIOPHEN UFH Control C2, REF 223901
Terminated		 GGNK051472
Feb 18, 2016TEM Systems Inc
ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thr
Terminated		 GGNK083842
Dec 16, 2013Instrumentation Laboratory Co.
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Terminated		 GGNK021022
K021023 +1
Dec 16, 2013Instrumentation Laboratory Co.
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Terminated		 GGNK021022
K021023 +1
Dec 16, 2013Instrumentation Laboratory Co.
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Terminated		 GGNK021022
K021023 +1
Feb 16, 2012Diagnostica Stago, Inc.
STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on
Terminated		 GGNK943518
Aug 10, 2010International Technidyne Corp.
International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic 15 vials For performance of Level 1 qualit
Terminated		 GGNK944691
Jul 28, 2010International Technidyne Corporation
GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk. Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125. Intended to be used t
Terminated		 GGNK944691
Jul 28, 2010International Technidyne Corporation
GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061600. Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. Intended to be used
Terminated		 GGNK944691
Jun 11, 2010International Technidyne Corporation
directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.
Terminated		 GGNK944691

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