GIZ · Plasma, Control, Normal
Hematology · 21 CFR 864.5425 · Class 2
Overview
| Product Code | GIZ |
|---|---|
| Device Name | Plasma, Control, Normal |
| Regulation | 21 CFR 864.5425 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Classification Rationale
Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060968 | STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW | Wortham Laboratories, Inc. | May 15, 2007 | SESE |
| K042941 | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS | Dade Behring, Inc. | Dec 2, 2004 | SESE |
| K023309 | CONTROL PLASMA N | Dade Behring, Inc. | Nov 1, 2002 | SESE |
| K013708 | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | Precision Biologic | Dec 10, 2001 | SESE |
| K003328 | ACCUCLOT CONTROL I, MODEL A4089 | Sigma Diagnostics, Inc. | Mar 1, 2001 | SESE |
| K001256 | CONTROL PLASMA N | Dade Behring, Inc. | May 24, 2000 | SESE |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | Pacific Hemostasis | Dec 1, 1998 | SESE |
| K973274 | ACCUCOLOR HIGH CALIBRATOR (A3089) | Sigma Diagnostics, Inc. | Oct 31, 1997 | SESE |
| K961814 | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | Cardiovascular Diagnostics, Inc. | Aug 13, 1996 | SESE |
| K941737 | SPECIALTY ASSAYED CONTROL-1 | Helena Laboratories | Oct 7, 1994 | SESE |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | American Diagnostica, Inc. | Sep 19, 1994 | SESE |
| K924403 | CONTROL PLASMA N | Behring Diagnostics, Inc. | Feb 22, 1994 | SESE |
| K932145 | COAGULATION REFERENCE PLASMA, NORMAL | American Diagnostic Corp. | Oct 18, 1993 | SESE |
| K922021 | UNICALIBRATOR KIT | American Bioproducts Co. | Jun 9, 1992 | SESE |
| K905203 | COAGULATION REFERENCE PLASMA, NORMAL | Medical Diagnostic Technologies, Inc. | Dec 28, 1990 | SESE |
| K895262 | NORMAL COAGULATION CONTROL PLASMA (NCCP) | Medical Diagnostic Technologies, Inc. | Oct 6, 1989 | SESE |
| K893784 | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | Jun 23, 1989 | SESE |
| K893783 | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | Jun 23, 1989 | SESE |
| K891179 | EDL NORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | Apr 10, 1989 | SESE |
| K880712 | CLP NORMAL COAGULATION CONTROL | Creative Laboratory Products, Inc. | May 6, 1988 | SESE |
Top Applicants
- Dade Behring, Inc. — 3 clearances
- Analytical Control Systems, Inc. — 2 clearances
- Medical Diagnostic Technologies, Inc. — 2 clearances
- Sigma Diagnostics, Inc. — 2 clearances
- American Bioproducts Co. — 1 clearance
