510(k) K971919
K971919 is an FDA 510(k) premarket notification submitted by Flexsite Diagnostics, Inc. for the device "EZCHEK/HBA BLOOD COLLECTION KIT". The FDA issued a decision of Substantially Equivalent on September 5, 1997. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Flexsite Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 1997
- Date Received
- May 23, 1997
- 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