HPC TM (Heparinized Plasma Control)
FDA 510(k) K770188 · Bio/Data Corp.
510(k) numberK770188
Submission
- Device name
- HPC TM (Heparinized Plasma Control)
- Applicant
- Bio/Data Corp.
Mchenry, IL, US - Received
- January 28, 1977
- Decision date
- February 18, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGC – Control, Plasma, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K062306 | Plasmacon N, Plasmacon L-1, Plasmacon L-2GGC · Traditional | R2 Diagnostics, Inc. | 03/16/2007SE |
| K061803 | Sta - Control la 1+2GGC · Traditional | Diagnostica Stago, Inc. | 07/28/2006SE |
| K032804 | Cryocheck Weak Lupus Positive ControlGGC · Traditional | Precision Biologic | 11/03/2003SE |
| K023312 | Control Plasma PGGC · Traditional | Dade Behring, Inc. | 11/01/2002SE |
| K020878 | Lyphochek Hemostasis, Models 798, 799GGC · Traditional | Bio-Rad | 04/15/2002SE |
| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | Sigma Diagnostics, Inc. | 02/06/2002SE |
| K012422 | K-Assay D-Dimer ControlsGGC · Traditional | Kamiya Biomedical Co. | 08/21/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | Sigma Diagnostics, Inc. | 03/01/2001SE |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001891 | Microsample Coagulation Analyzer, Model Mca 310-CGKP · Special | 07/12/2000SE |
| K943153 | Microsample Coagulation AnalyzerGKP · Traditional | 03/24/1995SE |
| K893650 | Platelet Aggregation Profiler Model PAP-4CJPA · Traditional | 06/23/1989SE |
| K881150 | Kinetic Fibrinogen AssayGIS · Traditional | 03/28/1988SE |
| K873382 | Platelet Extract ReagentGGW · Traditional | 11/20/1987SE |
| K860751 | Von Willebrand Fac. Defic. Abnormal Control PlasmaJPK · Traditional | 03/18/1986SE |
| K860342 | Microsample Coagulation Analyser, Model 110WPJPA · Traditional | 03/04/1986SE |
| K854546 | Microsample Coagulation Analyser Model 110PJPA · Traditional | 01/07/1986SE |
| K853897 | Citrex HGGW · Traditional | 10/10/1985SE |
| K853246 | Calcium ChlorideJPA · Traditional | 08/13/1985SE |
Questions and answers
When was HPC TM (Heparinized Plasma Control) cleared by the FDA?
HPC TM (Heparinized Plasma Control) (K770188) received a 510(k) decision of Substantially Equivalent on February 18, 1977, 21 days after the submission was received.
What is the product code of K770188?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.