510(k) K871975
K871975 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "MULTICHEM TOTAL PROTEIN REAGENT #S0928". The FDA issued a decision of Substantially Equivalent on Jun 5, 1987. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Simmler, Inc. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 5, 1987
- Date Received
- May 22, 1987
- 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