510(k) K812985
- Device
- AGGLUTEX MORPHINE TEST KIT
- Applicant
- HOFFMANN-LA ROCHE, INC.
- 510(k) number
- K812985
- Product code
- DDF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-12-31
- Date received
- 1981-10-26
- Regulation
- 866.5735
- Classification name
- Prothrombin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DDF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910617 | NATIVE PROTHROMBIN ANTIGEN EIA | Organon Teknika Corp. | 1991-05-15 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases