510(k) K903228
- Device
- EMIT ETS PLUS ETHYL ALCOHOL ASSAY
- Applicant
- SYVA CO.
- 510(k) number
- K903228
- Product code
- DMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-17
- Date received
- 1990-07-23
- Regulation
- 862.3040
- Classification name
- Potassium Dichromate Specific Reagent For Alcohol
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROGERS, JR.
- Address
- 900 Arastradero Rd. P.O. Box 10058 Palo Alto CA US 94303 94303
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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