Product code GGC
- Device name
- Control, Plasma, Abnormal
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5425
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102552 | HEMOSIL LA POSITIVE CONTROL | Instrumentation Laboratory CO | 2011-04-05 |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | Helena Laboratories | 2010-12-15 |
| K062306 | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | R2 Diagnostics, Inc. | 2007-03-16 |
| K061803 | STA - CONTROL LA 1+2 | Diagnostica Stago, Inc. | 2006-07-28 |
| K032804 | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | Precision Biologic | 2003-11-03 |
| K023312 | CONTROL PLASMA P | Dade Behring, Inc. | 2002-11-01 |
| K020878 | LYPHOCHEK HEMOSTASIS, MODELS 798, 799 | Bio-Rad | 2002-04-15 |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | Sigma Diagnostics, Inc. | 2002-02-06 |
| K012422 | K-ASSAY D-DIMER CONTROLS | Kamiya Biomedical Co. | 2001-08-21 |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | Sigma Diagnostics, Inc. | 2001-03-01 |
| K993332 | GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 | Gradipore , Ltd. | 2000-02-16 |
| K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | Pacific Hemostasis | 1998-12-01 |
| K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | Pacific Hemostasis | 1998-12-01 |
| K961370 | LA POSITIVE CONTROL PLASMA | Medical Diagnostic Technologies, Inc. | 1996-05-24 |
| K955040 | AT-III CONTROL PLASMA KIT | American Bioproducts Co. | 1996-01-31 |
| K952623 | CRYO CHECK LUPUS PLASMA | Precision Biologicals, Inc. | 1995-11-06 |
| K952624 | CRYO CHECK ABNORMAL REFERENCE CHECK I & II | Precision Biologicals, Inc. | 1995-10-30 |
| K945856 | POSITIVE LUPUS ANTICOAGULANT PLASMA | George King Bio-Medical, Inc. | 1995-10-05 |
| K952338 | STA-COAG CONTROL [P] PLUS KIT | American Bioproducts Co. | 1995-09-21 |
| K941872 | SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 | Helena Laboratories | 1994-11-21 |
| K930267 | BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL | Biomerieux Vitek, Inc. | 1994-03-22 |
| K924401 | PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) | Behring Diagnostics, Inc. | 1994-02-22 |
| K924402 | CONTROL PLASMA U | Behring Diagnostics, Inc. | 1994-02-22 |
| K930959 | FACTOR CONTROL [P] | American Bioproducts Co. | 1993-05-20 |
| K930923 | COAG-CONTROL | American Bioproducts Co. | 1993-04-27 |
| K924405 | CONTROL PLASMA P | Behring Diagnostics, Inc. | 1992-12-01 |
| K921665 | AVK CONTROL I & II | American Bioproducts Co. | 1992-06-09 |
| K911885 | DADE(R) PROTEIN C ABNORMAL CONTRAL | Baxter Healthcare Corp | 1991-06-11 |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | Medi-Tech, Inc. | 1990-10-22 |
| K901233 | ORTHO ABNORMAL PROTEIN C CONTROL PLASMA | Ortho Diagnostic Systems, Inc. | 1990-04-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00198815000107 | Recombinant Factor VIII Substrate, Porcine Sequence | Takeda Pharmaceuticals U.S.A., Inc. | 2025-08-01 |
| 00842768019685 | LA Control High | Siemens Healthcare Diagnostics Products GmbH | 2024-03-29 |
| 00842768019678 | LA Control Low | Siemens Healthcare Diagnostics Products GmbH | 2024-03-29 |
| 00630414640013 | LA Control Low | Siemens Healthcare Diagnostics Products GmbH | 2024-03-29 |
| 00630414640099 | LA Control High | Siemens Healthcare Diagnostics Products GmbH | 2024-03-29 |
| 00842768019470 | Dade Ci-Trol Coagulation Control Level 1 | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640167 | Dade Ci-Trol Coagulation Control Level 1 | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768018589 | Control Plasma P | Siemens Healthcare Diagnostics Products GmbH | 2024-02-19 |
| 00630414639703 | Control Plasma P | Siemens Healthcare Diagnostics Products GmbH | 2024-02-19 |
| 00815696021341 | George King SysCOR-40 Control Kit | GEORGE KING BIO-MEDICAL, INC | 2023-03-15 |
| 00817869020243 | Animal Plasma Control Level II | ANALYTICAL CONTROL SYSTEMS INC | 2019-01-31 |
| 10859394006061 | PlasmaCon N | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006078 | PlasmaCon L1 | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006139 | PlasmaCon LA | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006122 | PlasmaCon LA | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006115 | LupoTek Correctin VL | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006108 | LupoTek Detectin VL | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006085 | PlasmaCon L2 | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 00843876000077 | CRYOcheck™ Abnormal 1 Reference Control | Precision Biologic Inc | 2016-09-23 |
| 00843876000084 | CRYOcheck™ Abnormal 1 Reference Control | Precision Biologic Inc | 2016-09-23 |
| 00843876000145 | CRYOcheck™ Lupus Positive Control | Precision Biologic Inc | 2016-09-23 |
| 00843876000152 | CRYOcheck™ Lupus Positive Control | Precision Biologic Inc | 2016-09-23 |
| 03607450002010 | STA® - Control LA 1 + 2 | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450006766 | STA® - Coag Control N + ABN | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450006780 | STA® - System Control N + P | DIAGNOSTICA STAGO | 2016-09-15 |
| M52553020 | Coagulation S.A.C.-2 (Specialty Assay Control) | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| 00815696020498 | George King SysCOR Plus Kit | GEORGE KING BIO-MEDICAL, INC | 2016-08-19 |
| 00815696020481 | George King SysCOR Kit | GEORGE KING BIO-MEDICAL, INC | 2016-08-19 |
| 00815696020474 | George King AMR von Willebrand Kit | GEORGE KING BIO-MEDICAL, INC | 2016-08-19 |
| 00815696020467 | George King AMR Coagulation Kit | GEORGE KING BIO-MEDICAL, INC | 2016-08-19 |