510(k) K030826
- Device
- PRECISET DAT AMPHETAMINE
- Applicant
- QUANTIMETRIX CORP.
- 510(k) number
- K030826
- Product code
- DIJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-04-03
- Date received
- 2003-03-14
- Regulation
- 862.3550
- Classification name
- Lead, Delta Amino Levulinic Acid
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEBHARD NEYER
- Address
- 2005 Manhattan Beach Blvd. Redondo Beach CA US 90278 90278
Source Documents#
Other 510(k) Records For Product Code DIJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K792407 | ELVI-AMINOLEVULINIC ACID | Volu Sol Medical Industries | 1980-01-16 |
Legacy Summary#
summary
FDA Review#
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