GGC · Control, Plasma, Abnormal
Hematology · 21 CFR 864.5425 · Class 2
Overview
| Product Code | GGC |
|---|---|
| Device Name | Control, Plasma, Abnormal |
| Regulation | 21 CFR 864.5425 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Classification Rationale
Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K102552 | HEMOSIL LA POSITIVE CONTROL | Instrumentation Laboratory CO | Apr 5, 2011 | SESE |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | Helena Laboratories | Dec 15, 2010 | SESE |
| K062306 | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | R2 Diagnostics, Inc. | Mar 16, 2007 | SESE |
| K061803 | STA - CONTROL LA 1+2 | Diagnostica Stago, Inc. | Jul 28, 2006 | SESE |
| K032804 | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | Precision Biologic | Nov 3, 2003 | SESE |
| K023312 | CONTROL PLASMA P | Dade Behring, Inc. | Nov 1, 2002 | SESE |
| K020878 | LYPHOCHEK HEMOSTASIS, MODELS 798, 799 | Bio-Rad | Apr 15, 2002 | SESE |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | Sigma Diagnostics, Inc. | Feb 6, 2002 | SESE |
| K012422 | K-ASSAY D-DIMER CONTROLS | Kamiya Biomedical Co. | Aug 21, 2001 | SESE |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | Sigma Diagnostics, Inc. | Mar 1, 2001 | SESE |
| K993332 | GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 | Gradipore , Ltd. | Feb 16, 2000 | SESE |
| K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | Pacific Hemostasis | Dec 1, 1998 | SESE |
| K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | Pacific Hemostasis | Dec 1, 1998 | SESE |
| K961370 | LA POSITIVE CONTROL PLASMA | Medical Diagnostic Technologies, Inc. | May 24, 1996 | SESE |
| K955040 | AT-III CONTROL PLASMA KIT | American Bioproducts Co. | Jan 31, 1996 | SESE |
| K952623 | CRYO CHECK LUPUS PLASMA | Precision Biologicals, Inc. | Nov 6, 1995 | SESE |
| K952624 | CRYO CHECK ABNORMAL REFERENCE CHECK I & II | Precision Biologicals, Inc. | Oct 30, 1995 | SESE |
| K945856 | POSITIVE LUPUS ANTICOAGULANT PLASMA | George King Bio-Medical, Inc. | Oct 5, 1995 | SESE |
| K952338 | STA-COAG CONTROL [P] PLUS KIT | American Bioproducts Co. | Sep 21, 1995 | SESE |
| K941872 | SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 | Helena Laboratories | Nov 21, 1994 | SESE |
Top Applicants
- American Bioproducts Co. — 5 clearances
- Analytical Control Systems, Inc. — 4 clearances
- Medical Diagnostic Technologies, Inc. — 4 clearances
- Behring Diagnostics, Inc. — 3 clearances
- Helena Laboratories — 2 clearances
