Plasma, Control, Normal
Plasma, Control, Normal (product code GIZ) is a quality control plasma preparation with normal coagulation activity, used to calibrate and monitor coagulation testing instruments and assays in hematology laboratories, ensuring test results fall within expected reference ranges. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.5425 in the Hematology specialty (HE), this device carries no special regulatory flags.
Basic Information
- Product Code
- GIZ
- Device Class
- FDA class 2
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 20 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K060968 | STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW | May 15, 2007 | Substantially Equivalent | WORTHAM LABORATORIES INC |
| K042941 | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS | Dec 02, 2004 | Substantially Equivalent | DADE BEHRING, INC. |
| K023309 | CONTROL PLASMA N | Nov 01, 2002 | Substantially Equivalent | DADE BEHRING, INC. |
| K013708 | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | Dec 10, 2001 | Substantially Equivalent | PRECISION BIOLOGIC |
| K003328 | ACCUCLOT CONTROL I, MODEL A4089 | Mar 01, 2001 | Substantially Equivalent | SIGMA DIAGNOSTICS, INC. |
| K001256 | CONTROL PLASMA N | May 24, 2000 | Substantially Equivalent | DADE BEHRING, INC. |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | Dec 01, 1998 | Substantially Equivalent | PACIFIC HEMOSTASIS |
| K973274 | ACCUCOLOR HIGH CALIBRATOR (A3089) | Oct 31, 1997 | Substantially Equivalent | SIGMA DIAGNOSTICS, INC. |
| K961814 | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | Aug 13, 1996 | Substantially Equivalent | CARDIOVASCULAR DIAGNOSTICS, INC. |
| K941737 | SPECIALTY ASSAYED CONTROL-1 | Oct 07, 1994 | Substantially Equivalent | HELENA LABORATORIES |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | Sep 19, 1994 | Substantially Equivalent | AMERICAN DIAGNOSTICA, INC. |
| K924403 | CONTROL PLASMA N | Feb 22, 1994 | Substantially Equivalent | BEHRING DIAGNOSTICS, INC. |
| K932145 | COAGULATION REFERENCE PLASMA, NORMAL | Oct 18, 1993 | Substantially Equivalent | AMERICAN DIAGNOSTIC CORP. |
| K922021 | UNICALIBRATOR KIT | Jun 09, 1992 | Substantially Equivalent | AMERICAN BIOPRODUCTS CO. |
| K905203 | COAGULATION REFERENCE PLASMA, NORMAL | Dec 28, 1990 | Substantially Equivalent | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
| K895262 | NORMAL COAGULATION CONTROL PLASMA (NCCP) | Oct 06, 1989 | Substantially Equivalent | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
| K893784 | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I | Jun 23, 1989 | Substantially Equivalent | ANALYTICAL CONTROL SYSTEMS, INC. |
| K893783 | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I | Jun 23, 1989 | Substantially Equivalent | ANALYTICAL CONTROL SYSTEMS, INC. |
| K891179 | EDL NORMAL COAGULATION CONTROL | Apr 10, 1989 | Substantially Equivalent | ELITE DIAGNOSTIC LTD. |
| K880712 | CLP NORMAL COAGULATION CONTROL | May 06, 1988 | Substantially Equivalent | CREATIVE LABORATORY PRODUCTS, INC. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.