ELVI-AMINOLEVULINIC ACID
FDA 510(k) clearance K792407 · decided 1980-01-16
Clearance details
- K-number
- K792407
- Device name
- ELVI-AMINOLEVULINIC ACID
- Applicant
- Volu Sol Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1979-11-26
- Decision date
- 1980-01-16
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- DIJ
- Device class
- 2
- Regulation number
- 862.3550
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PRECISET DAT AMPHETAMINE (K030826) | Quantimetrix Corp. | 2003-04-03 |
Recalls involving this device
No recalls on record reference this clearance.