510(k) K964960
K964960 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS UPRO SLIDES". The FDA issued a decision of Substantially Equivalent on February 18, 1997. The device falls under product code JGP (Lowry (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Johnson & Johnson Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1997
- Date Received
- December 11, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lowry (Colorimetric), Total Protein
- Device Class
- Class II
- Regulation Number
- 862.1635
- Review Panel
- CH
- Submission Type