510(k) K874438
K874438 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on Jan 21, 1988. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 21, 1988
- Date Received
- Oct 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Vancomycin
- Device Class
- Class II
- Regulation Number
- 862.3950
- Review Panel
- TX
- Submission Type
- 510(k)