510(k) K040146
K040146 is an FDA 510(k) premarket notification submitted by Interlab S.R.L. for the device "INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on May 4, 2004. The device falls under product code GKA (Abnormal Hemoglobin Quantitation), a Class II device regulated under 21 CFR 864.7415. Interlab S.R.L. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2004
- Date Received
- January 22, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Abnormal Hemoglobin Quantitation
- Device Class
- Class II
- Regulation Number
- 864.7415
- Review Panel
- HE
- Submission Type