Control, Plasma, Abnormal
FDA product code GGC · Class II (moderate risk) · 21 CFR 864.5425 · Hematology
40510(k) clearances
0PMA approvals
0recalls
Manufacturers
- American Bioproducts Co. 5
- Analytical Control Systems, Inc. 4
- Medical Diagnostic Technologies, Inc. 4
- Behring Diagnostics, Inc. 3
- Sigma Diagnostics, Inc. 2
- Helena Laboratories 2
- Pacific Hemostasis 2
- Precision Biologicals, Inc. 2
- Biomerieux Vitek, Inc. 1
- Instrumentation Laboratory CO 1
- Dade Behring, Inc. 1
- Bio-Rad 1
- Kamiya Biomedical Co. 1
- Gradipore , Ltd. 1
- George King Bio-Medical, Inc. 1
- Bio/Data Corp. 1
- Baxter Healthcare Corp 1
- Medi-Tech, Inc. 1
- Ortho Diagnostic Systems, Inc. 1
- Creative Laboratory Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102552 | Hemosil la Positive ControlGGC · Traditional | Instrumentation Laboratory CO | 04/05/2011SE |
| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | Helena Laboratories | 12/15/2010SE |
| K062306 | Plasmacon N, Plasmacon L-1, Plasmacon L-2GGC · Traditional | R2 Diagnostics, Inc. | 03/16/2007SE |
| K061803 | Sta - Control la 1+2GGC · Traditional | Diagnostica Stago, Inc. | 07/28/2006SE |
| K032804 | Cryocheck Weak Lupus Positive ControlGGC · Traditional | Precision Biologic | 11/03/2003SE |
| K023312 | Control Plasma PGGC · Traditional | Dade Behring, Inc. | 11/01/2002SE |
| K020878 | Lyphochek Hemostasis, Models 798, 799GGC · Traditional | Bio-Rad | 04/15/2002SE |
| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | Sigma Diagnostics, Inc. | 02/06/2002SE |
| K012422 | K-Assay D-Dimer ControlsGGC · Traditional | Kamiya Biomedical Co. | 08/21/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | Sigma Diagnostics, Inc. | 03/01/2001SE |
| K993332 | Gradiplasma la High, Gradiplasma la Low Models LAHP-1, LAHP-05, LALP-1, LALP-05GGC · Traditional | Gradipore , Ltd. | 02/16/2000SE |
| K984131 | Coagulation Control Level 3 (Abnormal)GGC · Traditional | Pacific Hemostasis | 12/01/1998SE |
| K984130 | Coagulation Control Level 2 (Abnormal)GGC · Traditional | Pacific Hemostasis | 12/01/1998SE |
| K961370 | La Positive Control PlasmaGGC · Traditional | Medical Diagnostic Technologies, Inc. | 05/24/1996SE |
| K955040 | At-Iii Control Plasma KitGGC · Traditional | American Bioproducts Co. | 01/31/1996SE |
| K952623 | Cryo Check Lupus PlasmaGGC · Traditional | Precision Biologicals, Inc. | 11/06/1995SE |
| K952624 | Cryo Check Abnormal Reference Check I & IIGGC · Traditional | Precision Biologicals, Inc. | 10/30/1995SE |
| K945856 | Positive Lupus Anticoagulant PlasmaGGC · Traditional | George King Bio-Medical, Inc. | 10/05/1995SE |
| K952338 | Sta-Coag Control [P] Plus KitGGC · Traditional | American Bioproducts Co. | 09/21/1995SE |
| K941872 | Specialty Assayed CONTROL-2 Cat. No. 5302GGC · Traditional | Helena Laboratories | 11/21/1994SE |
| K930267 | Biomerieux Uniplasmatrol Normal & AbnormalGGC · Traditional | Biomerieux Vitek, Inc. | 03/22/1994SE |
| K924402 | Control Plasma UGGC · Traditional | Behring Diagnostics, Inc. | 02/22/1994SE |
| K924401 | Pathoplasma(R) I & II (Path Citrated Human Plasma)GGC · Traditional | Behring Diagnostics, Inc. | 02/22/1994SE |
| K930959 | Factor Control [P]GGC · Traditional | American Bioproducts Co. | 05/20/1993SE |
| K930923 | Coag-ControlGGC · Traditional | American Bioproducts Co. | 04/27/1993SE |
| K924405 | Control Plasma PGGC · Traditional | Behring Diagnostics, Inc. | 12/01/1992SE |
| K921665 | Avk Control I & IIGGC · Traditional | American Bioproducts Co. | 06/09/1992SE |
| K911885 | Dade(R) Protein C Abnormal ContralGGC · Traditional | Baxter Healthcare Corp | 06/11/1991SE |
| K904073 | Coagulation Reference Plasma, AbnormalGGC · Traditional | Medi-Tech, Inc. | 10/22/1990SE |
| K901233 | Ortho Abnormal Protein C Control PlasmaGGC · Traditional | Ortho Diagnostic Systems, Inc. | 04/11/1990SE |
| K900782 | Heparin Control Plasma, for Use in ApttGGC · Traditional | Medical Diagnostic Technologies, Inc. | 03/27/1990SE |
| K895261 | Abnormal Coagulation Control PLASMA-2 (ACCP-2)GGC · Traditional | Medical Diagnostic Technologies, Inc. | 10/06/1989SE |
| K895260 | Abnormal Coagulation Control PLASMA-1 (ACCP-1)GGC · Traditional | Medical Diagnostic Technologies, Inc. | 10/06/1989SE |
| K894425 | Acs Human Plasma Coagulation Control Level IIIGGC · Traditional | Analytical Control Systems, Inc. | 08/03/1989SE |
| K894338 | Acs Animal Plasma Coagulation Control Level IIIGGC · Traditional | Analytical Control Systems, Inc. | 07/25/1989SE |
| K893971 | Acs Animal Plasma Coagulation Control Level IIGGC · Traditional | Analytical Control Systems, Inc. | 07/25/1989SE |
| K893970 | Acs Human Plasma Coagulation Control Level IIGGC · Traditional | Analytical Control Systems, Inc. | 07/25/1989SE |
| K881510 | CLP Abnormal Coagulation ControlGGC · Traditional | Creative Laboratory Products, Inc. | 05/06/1988SE |
| K871420 | Herpes 1 and 2 MicroassaysGGC · Traditional | Diamedix Corp. | 12/11/1987SE |
| K770188 | HPC TM (Heparinized Plasma Control)GGC · Traditional | Bio/Data Corp. | 02/18/1977SE |