510(k) K801439
K801439 is an FDA 510(k) premarket notification submitted by Environmental Sciences Assoc., Inc. for the device "MODEL 5100 ELECTROCHEMICAL DETECTOR". The FDA issued a decision of Substantially Equivalent on July 21, 1980. The device falls under product code LEQ (Detectors, Electrochemical, Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Environmental Sciences Assoc., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1980
- Date Received
- June 20, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detectors, Electrochemical, Liquid Chromatography
- Device Class
- Class I
- Regulation Number
- 862.2260
- Review Panel
- TX
- Submission Type