510(k) K921977
K921977 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SYNERGY SCREEN TEST, MODIFICATION". The FDA issued a decision of Substantially Equivalent on Oct 12, 1993. The device falls under product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems), a Class II device regulated under 21 CFR 866.1640. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 12, 1993
- Date Received
- Apr 21, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
- 510(k)