510(k) K924289
K924289 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "KALLESTAD RSV MICROPLATE EIA". The FDA issued a decision of Substantially Equivalent on February 12, 1993. The device falls under product code MCE (Respiratory Syncytial Virus - Elisa), a Class I device regulated under 21 CFR 866.3480. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1993
- Date Received
- August 21, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respiratory Syncytial Virus - Elisa
- Device Class
- Class I
- Regulation Number
- 866.3480
- Review Panel
- MI
- Submission Type