510(k) K884184
K884184 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE". The FDA issued a decision of Substantially Equivalent on Mar 28, 1989. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 28, 1989
- Date Received
- Oct 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Assay, Glycosylated Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7470
- Review Panel
- HE
- Submission Type
- 510(k)