510(k) K792407
- Device
- ELVI-AMINOLEVULINIC ACID
- Applicant
- VOLU SOL MEDICAL INDUSTRIES
- 510(k) number
- K792407
- Product code
- DIJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-16
- Date received
- 1979-11-26
- Regulation
- 862.3550
- Classification name
- Lead, Delta Amino Levulinic Acid
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DIJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K030826 | PRECISET DAT AMPHETAMINE | Quantimetrix Corp. | 2003-04-03 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases