510(k) K881258
K881258 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II". The FDA issued a decision of Substantially Equivalent on May 27, 1988. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1988
- Date Received
- Mar 23, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Calibrator, Multi-Analyte Mixture
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type
- 510(k) Exempt