510(k) K921573
K921573 is an FDA 510(k) premarket notification submitted by Clark Laboratories, Inc. for the device "RUBELLA IGM". The FDA issued a decision of Substantially Equivalent on August 27, 1992. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Clark Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1992
- Date Received
- April 2, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorbent Assay, Rubella
- Device Class
- Class II
- Regulation Number
- 866.3510
- Review Panel
- MI
- Submission Type