FDA Product Code
FDA Product Code GGC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5425
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K102552 | HEMOSIL LA POSITIVE CONTROL | Instrumentation Laboratory CO | 2011-04-05 | Traditional | PDF ↗ |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | Helena Laboratories | 2010-12-15 | Traditional | PDF ↗ |
| K062306 | PLASMACON N, PLASMACON L-1, PLASMACON L-2 | R2 Diagnostics, Inc. | 2007-03-16 | Traditional | PDF ↗ |
| K061803 | STA - CONTROL LA 1+2 | Diagnostica Stago, Inc. | 2006-07-28 | Traditional | PDF ↗ |
| K032804 | CRYOCHECK WEAK LUPUS POSITIVE CONTROL | Precision Biologic | 2003-11-03 | Traditional | PDF ↗ |
| K023312 | CONTROL PLASMA P | Dade Behring, Inc. | 2002-11-01 | Traditional | PDF ↗ |
| K020878 | LYPHOCHEK HEMOSTASIS, MODELS 798, 799 | Bio-Rad | 2002-04-15 | Traditional | PDF ↗ |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | Sigma Diagnostics, Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K012422 | K-ASSAY D-DIMER CONTROLS | Kamiya Biomedical Co. | 2001-08-21 | Traditional | PDF ↗ |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | Sigma Diagnostics, Inc. | 2001-03-01 | Traditional | PDF ↗ |
| K993332 | GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 | Gradipore , Ltd. | 2000-02-16 | Traditional | PDF ↗ |
| K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | Pacific Hemostasis | 1998-12-01 | Traditional | PDF ↗ |
| K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | Pacific Hemostasis | 1998-12-01 | Traditional | PDF ↗ |
| K961370 | LA POSITIVE CONTROL PLASMA | Medical Diagnostic Technologies, Inc. | 1996-05-24 | Traditional | PDF ↗ |
| K955040 | AT-III CONTROL PLASMA KIT | American Bioproducts Co. | 1996-01-31 | Traditional | PDF ↗ |
| K952623 | CRYO CHECK LUPUS PLASMA | Precision Biologicals, Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K952624 | CRYO CHECK ABNORMAL REFERENCE CHECK I & II | Precision Biologicals, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K945856 | POSITIVE LUPUS ANTICOAGULANT PLASMA | George King Bio-Medical, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K952338 | STA-COAG CONTROL [P] PLUS KIT | American Bioproducts Co. | 1995-09-21 | Traditional | PDF ↗ |
| K941872 | SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 | Helena Laboratories | 1994-11-21 | Traditional | PDF ↗ |
| K930267 | BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL | Biomerieux Vitek, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K924402 | CONTROL PLASMA U | Behring Diagnostics, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K924401 | PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) | Behring Diagnostics, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K930959 | FACTOR CONTROL [P] | American Bioproducts Co. | 1993-05-20 | Traditional | PDF ↗ |
| K930923 | COAG-CONTROL | American Bioproducts Co. | 1993-04-27 | Traditional | PDF ↗ |
| K924405 | CONTROL PLASMA P | Behring Diagnostics, Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K921665 | AVK CONTROL I & II | American Bioproducts Co. | 1992-06-09 | Traditional | PDF ↗ |
| K911885 | DADE(R) PROTEIN C ABNORMAL CONTRAL | Baxter Healthcare Corp | 1991-06-11 | Traditional | PDF ↗ |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | Medi-Tech, Inc. | 1990-10-22 | Traditional | PDF ↗ |
| K901233 | ORTHO ABNORMAL PROTEIN C CONTROL PLASMA | Ortho Diagnostic Systems, Inc. | 1990-04-11 | Traditional | PDF ↗ |
| K900782 | HEPARIN CONTROL PLASMA, FOR USE IN APTT | Medical Diagnostic Technologies, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K895260 | ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1) | Medical Diagnostic Technologies, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K895261 | ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) | Medical Diagnostic Technologies, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K894425 | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III | Analytical Control Systems, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K894338 | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III | Analytical Control Systems, Inc. | 1989-07-25 | Traditional | PDF ↗ |
| K893971 | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II | Analytical Control Systems, Inc. | 1989-07-25 | Traditional | PDF ↗ |
| K893970 | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II | Analytical Control Systems, Inc. | 1989-07-25 | Traditional | PDF ↗ |
| K881510 | CLP ABNORMAL COAGULATION CONTROL | Creative Laboratory Products, Inc. | 1988-05-06 | Traditional | PDF ↗ |
| K871420 | HERPES 1 AND 2 MICROASSAYS | Diamedix Corp. | 1987-12-11 | Traditional | PDF ↗ |
| K770188 | HPC TM (HEPARINIZED PLASMA CONTROL) | Bio/Data Corp. | 1977-02-18 | Traditional | PDF ↗ |
Product code GGC · Class II · Hematology. Data: openFDA.