510(k) K930845
- Device
- Roche Abuscreen Ontrak For Methadone
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K930845
- Product code
- DIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-04-20
- Date received
- 1993-02-18
- Regulation
- 862.3620
- Classification name
- Hemagglutination Inhibition, Methadone
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL L KRIEGER
- Address
- 1080 Us Hwy. 202 Branchburg NJ US 08876 08876
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DIW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950182 | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-21 |
| K801509 | HI-M-TEST FOR METHADONE TEST #2 | Technam, Inc. | 1980-07-14 |
| K760075 | KIT, METHADONE (TOXI-PAK IMMUNO HI) | J.T. Baker Chemical Co. | 1976-07-20 |