510(k) K900733
K900733 is an FDA 510(k) premarket notification submitted by Elite Technology, Inc. for the device "PROTEIN TEST FOR URINE AND CSF". The FDA issued a decision of Substantially Equivalent on Jul 10, 1990. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Elite Technology, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 1990
- Date Received
- Feb 16, 1990
- 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
- 510(k) Exempt