510(k) K823680
- Device
- Coat-a-count Morphine Kit & Components
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- 510(k) number
- K823680
- Product code
- DDE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-05
- Date received
- 1982-12-07
- Regulation
- 866.5200
- Classification name
- Carbonic Anhydrase C, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents#
510(k) summary PDF not indicated by FDA