510(k) K901276
- Device
- Hemacon-doa(tm) Drugs Of Abuse Whole Blood Control
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- 510(k) number
- K901276
- Product code
- DIT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-04-26
- Date received
- 1990-03-19
- Regulation
- 862.3100
- Classification name
- Thin Layer Chromatography, Amphetamine
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH B ASARCH
- Address
- 5700 W. 96th St. Los Angeles CA US 90045 90045
FDA Registration Numbers#
- 2031229
Source Documents#
510(k) summary PDF not indicated by FDA