510(k) K980499
K980499 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST ANTITHROMBIN". The FDA issued a decision of Substantially Equivalent on April 2, 1998. The device falls under product code JBQ (Antithrombin Iii Quantitation), a Class II device regulated under 21 CFR 864.7060. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 1998
- Date Received
- February 9, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antithrombin Iii Quantitation
- Device Class
- Class II
- Regulation Number
- 864.7060
- Review Panel
- HE
- Submission Type