510(k) K923266
K923266 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "NOVA TOTAL PROTEIN MODULE". The FDA issued a decision of Substantially Equivalent on August 12, 1992. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1992
- Date Received
- July 2, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biuret (Colorimetric), Total Protein
- Device Class
- Class II
- Regulation Number
- 862.1635
- Review Panel
- CH
- Submission Type