510(k) K032012
K032012 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "HOMOCYSTEINE MICROTITER PLATE ASSAY". The FDA issued a decision of Substantially Equivalent on September 3, 2003. The device falls under product code LPS (Urinary Homocystine (Nonquantitative) Test System), a Class II device regulated under 21 CFR 862.1377. Diazyme Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2003
- Date Received
- June 30, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urinary Homocystine (Nonquantitative) Test System
- Device Class
- Class II
- Regulation Number
- 862.1377
- Review Panel
- CH
- Submission Type