510(k) K864212
K864212 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST 97573-15, PLASMINOGEN ASSAY". The FDA issued a decision of Substantially Equivalent on December 4, 1986. The device falls under product code DDX (Plasminogen, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5715. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1986
- Date Received
- October 28, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plasminogen, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5715
- Review Panel
- HE
- Submission Type