510(k) K896582
K896582 is an FDA 510(k) premarket notification submitted by Primus, Inc. for the device "DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)". The FDA issued a decision of Substantially Equivalent on June 28, 1990. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Primus, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1990
- Date Received
- November 17, 1989
- 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