GGC — Control, Plasma, Abnormal Class II
FDA product code GGC covers "Control, Plasma, Abnormal", a Class II medical device regulated under 21 CFR 864.5425. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GGC
- Device Class
- Class II
- Regulation Number
- 864.5425
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K102552 | instrumentation laboratory | HEMOSIL LA POSITIVE CONTROL | April 5, 2011 |
| K100103 | helena laboratories | SPECIALTY ASSAYED CONTROL-2 | December 15, 2010 |
| K062306 | r2 diagnostics | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | March 16, 2007 |
| K061803 | diagnostica stago | STA - CONTROL LA 1+2 | July 28, 2006 |
| K032804 | precision biologic | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | November 3, 2003 |
| K023312 | dade behring | CONTROL PLASMA P | November 1, 2002 |
| K020878 | bio-rad | LYPHOCHEK HEMOSTASIS, MODELS 798, 799 | April 15, 2002 |
| K020109 | sigma diagnostics | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | February 6, 2002 |
| K012422 | kamiya biomedical | K-ASSAY D-DIMER CONTROLS | August 21, 2001 |
| K003329 | sigma diagnostics | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | March 1, 2001 |
| K993332 | gradipore | GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 | February 16, 2000 |
| K984130 | pacific hemostasis | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | December 1, 1998 |
| K984131 | pacific hemostasis | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | December 1, 1998 |
| K961370 | medical diagnostic technologies | LA POSITIVE CONTROL PLASMA | May 24, 1996 |
| K955040 | american bioproducts | AT-III CONTROL PLASMA KIT | January 31, 1996 |
| K952623 | precision biologicals | CRYO CHECK LUPUS PLASMA | November 6, 1995 |
| K952624 | precision biologicals | CRYO CHECK ABNORMAL REFERENCE CHECK I & II | October 30, 1995 |
| K945856 | george king bio-medical | POSITIVE LUPUS ANTICOAGULANT PLASMA | October 5, 1995 |
| K952338 | american bioproducts | STA-COAG CONTROL [P] PLUS KIT | September 21, 1995 |
| K941872 | helena laboratories | SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 | November 21, 1994 |