510(k) K792555
- Device
- ELVI NON-ESTERIFIED FATTY ACIDS
- Applicant
- VOLU SOL MEDICAL INDUSTRIES
- 510(k) number
- K792555
- Product code
- JLH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-16
- Date received
- 1979-12-10
- Regulation
- 862.1290
- Classification name
- Titrimetric, Fatty Acids
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3034731501
- 3003741796
- 3003419906
- 3003522182
- 3004493545
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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