Elvi-Aminolevulinic Acid
FDA 510(k) K792407 · Volu Sol Medical Industries
510(k) numberK792407
Submission
- Device name
- Elvi-Aminolevulinic Acid
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- November 26, 1979
- Decision date
- January 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIJ – Lead, Delta Amino Levulinic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3550
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K030826 | Preciset Dat AmphetamineDIJ · Traditional | Quantimetrix Corp. | 04/03/2003SE |
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| K822036 | Volu-Sol DecalciferKDX · Traditional | 08/03/1982SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | 08/03/1982SE |
| K812906 | Elvi Biclot 816KQG · Traditional | 07/22/1982SE |
| K821541 | Hematoxylin IIIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Elvi-Aminolevulinic Acid cleared by the FDA?
Elvi-Aminolevulinic Acid (K792407) received a 510(k) decision of Substantially Equivalent on January 16, 1980, 51 days after the submission was received.
What is the product code of K792407?
The FDA product code is DIJ – Lead, Delta Amino Levulinic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.3550.