510(k) K801432
K801432 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "HEMOPEXIN NEPHELOMETRIC ASSAY". The FDA issued a decision of Substantially Equivalent on July 8, 1980. The device falls under product code CZX (Hemopexin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5490. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 1980
- Date Received
- June 18, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemopexin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5490
- Review Panel
- IM
- Submission Type