510(k) K931721
K931721 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST FIBRINOGEN-C". The FDA issued a decision of Substantially Equivalent on August 13, 1993. The device falls under product code KQJ (System, Fibrinogen Determination), a Class II device regulated under 21 CFR 864.7340. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1993
- Date Received
- April 7, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Fibrinogen Determination
- Device Class
- Class II
- Regulation Number
- 864.7340
- Review Panel
- HE
- Submission Type