Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5425](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5425) → GIZ — Plasma, Control, Normal # GIZ · Plasma, Control, Normal _Hematology · 21 CFR 864.5425 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ ## Overview - **Product Code:** GIZ - **Device Name:** Plasma, Control, Normal - **Regulation:** [21 CFR 864.5425](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5425) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) ## 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](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K060968.md) | 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](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K042941.md) | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS | Dade Behring, Inc. | Dec 2, 2004 | SESE | | [K023309](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K023309.md) | CONTROL PLASMA N | Dade Behring, Inc. | Nov 1, 2002 | SESE | | [K013708](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K013708.md) | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | Precision Biologic | Dec 10, 2001 | SESE | | [K003328](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K003328.md) | ACCUCLOT CONTROL I, MODEL A4089 | Sigma Diagnostics, Inc. | Mar 1, 2001 | SESE | | [K001256](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K001256.md) | CONTROL PLASMA N | Dade Behring, Inc. | May 24, 2000 | SESE | | [K984129](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K984129.md) | COAGULATION CONTROL LEVEL 1 (NORMAL) | Pacific Hemostasis | Dec 1, 1998 | SESE | | [K973274](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K973274.md) | ACCUCOLOR HIGH CALIBRATOR (A3089) | Sigma Diagnostics, Inc. | Oct 31, 1997 | SESE | | [K961814](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K961814.md) | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | Cardiovascular Diagnostics, Inc. | Aug 13, 1996 | SESE | | [K941737](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K941737.md) | SPECIALTY ASSAYED CONTROL-1 | Helena Laboratories | Oct 7, 1994 | SESE | | [K935254](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K935254.md) | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | American Diagnostica, Inc. | Sep 19, 1994 | SESE | | [K924403](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K924403.md) | CONTROL PLASMA N | Behring Diagnostics, Inc. | Feb 22, 1994 | SESE | | [K932145](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K932145.md) | COAGULATION REFERENCE PLASMA, NORMAL | American Diagnostic Corp. | Oct 18, 1993 | SESE | | [K922021](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K922021.md) | UNICALIBRATOR KIT | American Bioproducts Co. | Jun 9, 1992 | SESE | | [K905203](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K905203.md) | COAGULATION REFERENCE PLASMA, NORMAL | Medical Diagnostic Technologies, Inc. | Dec 28, 1990 | SESE | | [K895262](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K895262.md) | NORMAL COAGULATION CONTROL PLASMA (NCCP) | Medical Diagnostic Technologies, Inc. | Oct 6, 1989 | SESE | | [K893784](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K893784.md) | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | Jun 23, 1989 | SESE | | [K893783](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K893783.md) | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I | Analytical Control Systems, Inc. | Jun 23, 1989 | SESE | | [K891179](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K891179.md) | EDL NORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | Apr 10, 1989 | SESE | | [K880712](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ/K880712.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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