510(k) K761168
K761168 is an FDA 510(k) premarket notification submitted by Brinkman Instruments, Inc. for the device "MAX L SYSTEM". The FDA issued a decision of Substantially Equivalent on December 10, 1976. The device falls under product code DPM (Columns, Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1976
- Date Received
- December 1, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Columns, Liquid Chromatography
- Device Class
- Class I
- Regulation Number
- 862.2260
- Review Panel
- TX
- Submission Type