510(k) K873936
K873936 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "MODIFIED PARAMAX GLUCOSE REAGENT". The FDA issued a decision of Substantially Equivalent on Nov 23, 1987. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. 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 25, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Hexokinase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type
- 510(k)