510(k) K980242
K980242 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST HEPARIN". The FDA issued a decision of Substantially Equivalent on March 19, 1998. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1998
- Date Received
- January 23, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Heparin
- Device Class
- Class II
- Regulation Number
- 864.7525
- Review Panel
- HE
- Submission Type