510(k) K770150
K770150 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "ELECTRO IMMUNO ASSAY KIT". The FDA issued a decision of Substantially Equivalent on February 1, 1977. The device falls under product code JZS (Electrophoresis Instrumentation), a Class I device regulated under 21 CFR 866.4500. Millipore Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1977
- Date Received
- January 24, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoresis Instrumentation
- Device Class
- Class I
- Regulation Number
- 866.4500
- Review Panel
- IM
- Submission Type