K-ASSAY D-DIMER CONTROLS
FDA 510(k) clearance K012422 · decided 2001-08-21
Clearance details
- K-number
- K012422
- Device name
- K-ASSAY D-DIMER CONTROLS
- Applicant
- Kamiya Biomedical Co.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-30
- Decision date
- 2001-08-21
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- GGC
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEMOSIL LA POSITIVE CONTROL (K102552) | Instrumentation Laboratory CO | 2011-04-05 |
| SPECIALTY ASSAYED CONTROL-2 (K100103) | Helena Laboratories | 2010-12-15 |
| PLASMACON N, PLASMACON L-1, PLASMACON L-2 (K062306) | R2 Diagnostics, Inc. | 2007-03-16 |
| STA - CONTROL LA 1+2 (K061803) | Diagnostica Stago, Inc. | 2006-07-28 |
| CRYOCHECK WEAK LUPUS POSITIVE CONTROL (K032804) | Precision Biologic | 2003-11-03 |
| CONTROL PLASMA P (K023312) | Dade Behring, Inc. | 2002-11-01 |
| LYPHOCHEK HEMOSTASIS, MODELS 798, 799 (K020878) | Bio-Rad | 2002-04-15 |
| SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (K020109) | Sigma Diagnostics, Inc. | 2002-02-06 |
| SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (K003329) | Sigma Diagnostics, Inc. | 2001-03-01 |
| GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 (K993332) | Gradipore , Ltd. | 2000-02-16 |
| COAGULATION CONTROL LEVEL 2 (ABNORMAL) (K984130) | Pacific Hemostasis | 1998-12-01 |
| COAGULATION CONTROL LEVEL 3 (ABNORMAL) (K984131) | Pacific Hemostasis | 1998-12-01 |
Recalls involving this device
No recalls on record reference this clearance.