FIBRINOGEN ASSAY KIT
FDA 510(k) clearance K896052 · decided 1989-11-09
Clearance details
- K-number
- K896052
- Device name
- FIBRINOGEN ASSAY KIT
- Applicant
- Medical Diagnostic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-10-18
- Decision date
- 1989-11-09
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- KQJ
- Device class
- 2
- Regulation number
- 864.7340
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Ventura, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Diagnostic Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS (K923593) | International Technidyne Corp. | 1992-09-22 |
| QBC FIBRINOGEN (K920258) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-06-26 |
Recalls involving this device
No recalls on record reference this clearance.