510(k) K761304
K761304 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "JTB 700 HEMATOLOGY ANALYZER". The FDA issued a decision of Substantially Equivalent on February 1, 1977. The device falls under product code JPJ (Red-Cell Indices, Calculated), a Class II device regulated under 21 CFR 864.5300. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1977
- Date Received
- December 22, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Red-Cell Indices, Calculated
- Device Class
- Class II
- Regulation Number
- 864.5300
- Review Panel
- HE
- Submission Type