KQJ · System, Fibrinogen Determination
Hematology · 21 CFR 864.7340 · Class 2
Overview
| Product Code | KQJ |
|---|---|
| Device Name | System, Fibrinogen Determination |
| Regulation | 21 CFR 864.7340 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
Classification Rationale
Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system 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 or fibrinogen standard intended for use with a fibrinogen determination system 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 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | Jul 24, 2025 | SESE |
| K073367 | HEMOSIL FIBRINOGEN-C | Instrumentation Laboratory CO | Dec 27, 2007 | SESE |
| K050928 | DADE THROMBIN REAGENT | Dade Behring, Inc. | Jun 29, 2005 | SESE |
| K971858 | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) | Sigma Diagnostics, Inc. | Oct 9, 1997 | SESE |
| K970189 | FIF TM | Panbio, Inc. | May 21, 1997 | SESE |
| K965113 | N-ASSAY TIA FIBRINOGEN TEST KIT | Crestat Diagnostics, Inc. | Apr 16, 1997 | SESE |
| K934326 | MULTIFIBREN U | Behring Diagnostics, Inc. | Apr 19, 1994 | SESE |
| K931721 | IL TEST FIBRINOGEN-C | Instrumentation Laboratory CO | Aug 13, 1993 | SESE |
| K922416 | FIBRINOGEN RID TEST KIT | The Binding Site, Ltd. | Mar 9, 1993 | SESE |
| K925988 | MULTIFIBREN | Behring Diagnostics, Inc. | Mar 1, 1993 | SESE |
| K923593 | HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS | International Technidyne Corp. | Sep 22, 1992 | SESE |
| K920258 | QBC FIBRINOGEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 26, 1992 | SESE |
| K900939 | SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) | Incstar Corp. | May 16, 1990 | SESE |
| K900895 | COAG-A-MATE - RA4 | Organon Teknika Corp. | Apr 16, 1990 | SESE |
| K896052 | FIBRINOGEN ASSAY KIT | Medical Diagnostic Technologies, Inc. | Nov 9, 1989 | SESE |
| K884179 | TURBOX FIBRINOGEN | Unipath , Ltd. | Dec 20, 1988 | SESE |
| K841366 | DIA FIBRIN | Diatech, Inc. | Jun 1, 1984 | SESE |
| K841020 | FIBRINOGEN ASSAY KIT | Helena Laboratories | May 2, 1984 | SESE |
| K840211 | FIBRI-PREST AUTOMATE HA34 | Wellcome Diagnostics | Mar 2, 1984 | SESE |
| K834571 | FIBRINOGEN TEST | Diatech, Inc. | Feb 4, 1984 | SESE |
Top Applicants
- Instrumentation Laboratory CO — 2 clearances
- Diatech, Inc. — 2 clearances
- Bio/Data Corp. — 2 clearances
- Behring Diagnostics, Inc. — 2 clearances
- Wellcome Diagnostics — 1 clearance
