510(k) K801439
- Device
- MODEL 5100 ELECTROCHEMICAL DETECTOR
- Applicant
- ENVIRONMENTAL SCIENCES ASSOC., INC.
- 510(k) number
- K801439
- Product code
- LEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-21
- Date received
- 1980-06-20
- Regulation
- 862.2260
- Classification name
- Detectors, Electrochemical, Liquid Chromatography
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003951180
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LEQ #
Legacy Summary#
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FDA Review#
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