Panels › Hematology › Product code GJS · Class 2
Test, Time, Prothrombin
Regulation 864.7750
0510(k)s in 12 months (127 all time)
0recalls in 12 months (73 all time)
68recalls that name a 510(k)
Top companies in GJS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2008 | Diagnostica Stago, Inc. STA Neoplastine CI Plus 10; Product Catalogue Number: 0667
Manufactured by Diagnostica Stago, Asnieres, France. Terminated |
GJS | None listed |
| Dec 18, 2008 | Diagnostica Stago, Inc. STA Neoplastine CI 10; Product Catalogue Number: 0666;
Manufactured by Diagnostica Stago, Asnieres, France. Terminated |
GJS | None listed |
| Jan 25, 2008 | International Technidyne Corporation ProTime Microcoagulation System Instrument:Catalogue Number:
PROTIMEINT, International Technidyne Corporation (ITC), Piscataway, NJ 08854 Terminated |
GJS | K951072 |
| Jan 25, 2008 | International Technidyne Corporation ProTime Microcoagulation System Instrument, Catalogue Number:
PROTIMEPST, International Technidyne Corporation (ITC), Piscataway, NJ 08854 Terminated |
GJS | K961835 |
| Jan 25, 2008 | International Technidyne Corporation ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Technidyne Corporation (ITC), Piscataway, NJ 08854 Terminated |
GJS | K010599 |
| Jul 3, 2007 | Diagnostica Stago, Inc. STA Neoplastine CI Plus (10), (cat. 0667).
12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT). Terminated |
GJS | K922040 |
| Apr 11, 2007 | Roche Diagnostics Corp. CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use). Terminated |
GJS | K930454 K962571 +2 |
| Jan 23, 2007 | Abbott Point of Care Inc. i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic.
Ref 04J50-01
24
IVD
Abbott Point of Care Inc.
104 Windsor Center Drive
East Windsor, NJ 08520
Product of Canada Terminated |
GJS | K020355 |
| Jan 13, 2007 | International Technidyne Corp. International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol. Terminated |
GJS | K951072 |
| Nov 30, 2006 | Roche Diagnostics Corp. CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per bo Terminated |
GJS | K930454 K962571 +2 |
| Jul 18, 2006 | Instrumentation Laboratory Co. Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance Reco Terminated |
GJS | K925604 |
| Jul 18, 2006 | Instrumentation Laboratory Co. HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipi Terminated |
GJS | K043184 |
| Nov 15, 2005 | HemoSense Inc HemoSense brand INRatio Prothombin Time Monitoring System,
Software Version 1.25.21;
Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134 Terminated |
GJS | K020679 K021923 |
| Oct 28, 2005 | Roche Diagnostics Corp. Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001. Terminated |
GJS | K994349 |
| Oct 28, 2005 | Roche Diagnostics Corp. Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001. Terminated |
GJS | K930454 K942884 +2 |
| Oct 28, 2005 | Roche Diagnostics Corp. Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003. Terminated |
GJS | K021190 K030845 +1 |
| May 18, 2005 | BIOMERIEUX, INC. Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704 Terminated |
GJS | K974566 |
| Nov 30, 2004 | Trinity Biotech USA AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, I Terminated |
GJS | K972796 |
| Oct 15, 2003 | Roche Diagnostics Corp. CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. catalog numbers 1937642 [packaged 48 strips per box] and 1937634 [packaged 12 strip Terminated |
GJS | K962571 K974569 |
| Oct 15, 2003 | bioMerieux MDA Simplastin L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969. Terminated |
GJS | None listed |
| Oct 15, 2003 | bioMerieux Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux, Terminated |
GJS | None listed |
| Mar 6, 2003 | Biomerieux, Inc. Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mi Terminated |
GJS | K864283 |
| Mar 6, 2003 | Biomerieux, Inc. BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704 Terminated |
GJS | K882214 |
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