TE-25 Coaguro Meter

FDA 510(k) K854686 · Future Impex Corp.

Substantially Equivalent

510(k) numberK854686

Submission

Device name
TE-25 Coaguro Meter
Applicant
Future Impex Corp.
Deerpark, NY, US
Received
November 20, 1985
Decision date
June 4, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JBP – Activated Whole Blood Clotting Time
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7140
Specialty
Hematology

Other 510(k)s with product code JBP

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K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerJBP · Special Sienco, Inc.01/04/2023SE
K062604Rapidteg Teg-Act TestJBP · Traditional Haemoscope Corp.01/31/2007SE
K032952Aiact KitJBP · Traditional Sienco, Inc.12/12/2003SE
K023582I-Stat Kaolin Act TestJBP · Traditional I-Stat Corporation09/08/2003SE
K020914Actalyke XL Activated Clotting Time Analyzer, Model 5770JBP · Traditional Helena Laboratories05/23/2002SE
K013078Actalyke Mini Activated Clotting Time Test System, Model 5750/5752JBP · Traditional Helena Laboratories01/10/2002SE
K002528Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer OptionJBP · Special Sienco, Inc.08/31/2000SE
K994194(Tas) Low Range Heparin Management Card RapidpointJBP · Traditional Cardiovascular Diagnostics, Inc.03/28/2000SE
K992571I-Stat SystemJBP · Traditional I-Stat Corp.02/10/2000SE
K992851Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro SystemJBP · Traditional Roche Diagnostics Corp.01/14/2000SE

More from Roche Diagnostics Corp.

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K854678Erma PC-602 PC-603 Blood Cell CounterGKL · Traditional 02/24/1986SE
K854677Erma PC-604 Blood Cell CounterGKL · Traditional 02/24/1986SE
K854679PHOTIC-100 SpectrophotometerJJQ · Traditional 02/20/1986SE
K843934Model {M-102 I-Channel Electro Cardiograph UnitDPS · Traditional 11/20/1984SE
K843984PM-80 PulmotesterBZG · Traditional 10/24/1984SE
K843700ST-200A W/Maximal Voluntary Ventillat- · Traditional 10/24/1984SE
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Questions and answers

When was TE-25 Coaguro Meter cleared by the FDA?

TE-25 Coaguro Meter (K854686) received a 510(k) decision of Substantially Equivalent on June 4, 1986, 196 days after the submission was received.

What is the product code of K854686?

The FDA product code is JBP – Activated Whole Blood Clotting Time, a Class II (moderate risk) device regulated under 21 CFR 864.7140.