510(k) K873520
K873520 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PARAMAX AMYLASE REAGENT". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code CJA (Amyloclastic, Amylase), a Class II device regulated under 21 CFR 862.1070. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1987
- Date Received
- September 1, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amyloclastic, Amylase
- Device Class
- Class II
- Regulation Number
- 862.1070
- Review Panel
- CH
- Submission Type