510(k) K861697
K861697 is an FDA 510(k) premarket notification submitted by Awareness Technology, Inc. for the device "SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)". The FDA issued a decision of Substantially Equivalent on August 19, 1986. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Awareness Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1986
- Date Received
- May 5, 1986
- 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