510(k) K925208
K925208 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION". The FDA issued a decision of Substantially Equivalent on December 28, 1992. The device falls under product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific), a Class II device regulated under 21 CFR 866.3305. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1992
- Date Received
- September 28, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- Device Class
- Class II
- Regulation Number
- 866.3305
- Review Panel
- MI
- Submission Type