HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
FDA 510(k) clearance K923593 · decided 1992-09-22
Clearance details
- K-number
- K923593
- Device name
- HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-20
- Decision date
- 1992-09-22
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- KQJ
- Device class
- 2
- Regulation number
- 864.7340
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (K251968) | Instrumentation Laboratory (IL) Co. | 2025-07-24 |
| HEMOSIL FIBRINOGEN-C (K073367) | Instrumentation Laboratory CO | 2007-12-27 |
| DADE THROMBIN REAGENT (K050928) | Dade Behring, Inc. | 2005-06-29 |
| SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) (K971858) | Sigma Diagnostics, Inc. | 1997-10-09 |
| FIF TM (K970189) | Panbio, Inc. | 1997-05-21 |
| N-ASSAY TIA FIBRINOGEN TEST KIT (K965113) | Crestat Diagnostics, Inc. | 1997-04-16 |
| MULTIFIBREN U (K934326) | Behring Diagnostics, Inc. | 1994-04-19 |
| IL TEST FIBRINOGEN-C (K931721) | Instrumentation Laboratory CO | 1993-08-13 |
| FIBRINOGEN RID TEST KIT (K922416) | The Binding Site, Ltd. | 1993-03-09 |
| MULTIFIBREN (K925988) | Behring Diagnostics, Inc. | 1993-03-01 |
| QBC FIBRINOGEN (K920258) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-06-26 |
| SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) (K900939) | Incstar Corp. | 1990-05-16 |
Recalls involving this device
No recalls on record reference this clearance.