510(k) K873532
K873532 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PARAMAX UREA NITROGEN REAGENT". The FDA issued a decision of Substantially Equivalent on Nov 23, 1987. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 23, 1987
- Date Received
- Sep 1, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device Class
- Class II
- Regulation Number
- 862.1770
- Review Panel
- CH
- Submission Type
- 510(k)