510(k) K880315
K880315 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DADE ANTITHROMBIN III CHROMOGENIC ASSAY". The FDA issued a decision of Substantially Equivalent on Mar 16, 1988. The device falls under product code JBQ (Antithrombin Iii Quantitation), a Class II device regulated under 21 CFR 864.7060. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 16, 1988
- Date Received
- Jan 26, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Antithrombin Iii Quantitation
- Device Class
- Class II
- Regulation Number
- 864.7060
- Review Panel
- HE
- Submission Type
- 510(k)