510(k) K931721
- Device
- IL TEST FIBRINOGEN-C
- Applicant
- INSTRUMENTATION LABORATORY CO.
- 510(k) number
- K931721
- Product code
- KQJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-08-13
- Date received
- 1993-04-07
- Regulation
- 864.7340
- Classification name
- System, Fibrinogen Determination
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WALLIS W CADY
- Address
- 113 Hartwell Ave. P.O. Box 9113 Lexington MA US 02173 02173
FDA Registration Numbers#
- 9710666
- 1217183
- 2431530
- 1181121
- 3037000637
- 9610806
- 1835316
- 1618982
- 2245451
- 3008386529
Source Documents#
Other 510(k) Records For Product Code KQJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | 2025-07-24 |
| K073367 | HEMOSIL FIBRINOGEN-C | Instrumentation Laboratory CO | 2007-12-27 |
| K050928 | DADE THROMBIN REAGENT | Dade Behring, Inc. | 2005-06-29 |
| K971858 | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) | Sigma Diagnostics, Inc. | 1997-10-09 |
| K970189 | FIF TM | Panbio, Inc. | 1997-05-21 |
| K965113 | N-ASSAY TIA FIBRINOGEN TEST KIT | Crestat Diagnostics, Inc. | 1997-04-16 |
| K934326 | MULTIFIBREN U | Behring Diagnostics, Inc. | 1994-04-19 |
| K922416 | FIBRINOGEN RID TEST KIT | The Binding Site, Ltd. | 1993-03-09 |
| K925988 | MULTIFIBREN | Behring Diagnostics, Inc. | 1993-03-01 |
| K923593 | HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS | International Technidyne Corp. | 1992-09-22 |
| K920258 | QBC FIBRINOGEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-06-26 |
| K900939 | SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) | Incstar Corp. | 1990-05-16 |
| K900895 | COAG-A-MATE - RA4 | Organon Teknika Corp. | 1990-04-16 |
| K896052 | FIBRINOGEN ASSAY KIT | Medical Diagnostic Technologies, Inc. | 1989-11-09 |
| K884179 | TURBOX FIBRINOGEN | Unipath , Ltd. | 1988-12-20 |
Legacy Summary#
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FDA Review#
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