510(k) K830480
- Device
- ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
- Applicant
- HOFFMANN-LA ROCHE, INC.
- 510(k) number
- K830480
- Product code
- KLN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-24
- Date received
- 1983-02-15
- Regulation
- 862.3250
- Classification name
- Radioimmunoassay, Cocaine Metabolite
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- 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
Other 510(k) Records For Product Code KLN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010868 | PSYCHEMEDICS RIA COCAINE ASSAY | Psychemedics Corp. | 2001-11-06 |
| K913867 | URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) | Immunalysis Corporation | 1991-09-19 |
| K913722 | ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | 1991-09-10 |
| K912756 | ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | 1991-07-26 |
| K910122 | TARGET COCAINE METABOLITE-R | V-Tech, Inc. | 1991-03-19 |
| K910123 | TARGET COCAINE METABOLITE-V | V-Tech, Inc. | 1991-03-19 |
| K910044 | MILENIA COCAINE METABOLITE | Diagnostic Products Corp. | 1991-02-13 |
| K905730 | ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) | Roche Diagnostic Systems, Inc. | 1991-01-15 |
| K904995 | ABUSCREEN ONLINE TM FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | 1990-11-28 |
| K880674 | MICROMEDIC CRACKPOT RIA KIT | Icn Micromedic Systems | 1988-10-06 |
| K871549 | RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] | Immunalysis Corporation | 1987-06-16 |
| K870740 | COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 | Diagnostic Products Corp. | 1987-03-19 |
| K862218 | DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT | Diagnostic Products Corp. | 1986-06-27 |
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