510(k) K911712
K911712 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STRATUS(R) AUTOMATED SAMPLE HANDLER". The FDA issued a decision of Substantially Equivalent on May 15, 1991. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1991
- Date Received
- Apr 17, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Station, Pipetting And Diluting, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2750
- Review Panel
- CH
- Submission Type
- 510(k) Exempt