510(k) K880651
K880651 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PARAMAX AMMONIA REAGENT". The FDA issued a decision of Substantially Equivalent on Mar 24, 1988. The device falls under product code JIF (Enzymatic Method, Ammonia), a Class I device regulated under 21 CFR 862.1065. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 24, 1988
- Date Received
- Feb 17, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Enzymatic Method, Ammonia
- Device Class
- Class I
- Regulation Number
- 862.1065
- Review Panel
- CH
- Submission Type
- 510(k)