510(k) K881816
- Device
- ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K881816
- Product code
- DKN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-28
- Date received
- 1988-04-28
- Regulation
- 862.3150
- Classification name
- Radioimmunoassay, Barbiturate
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ADRIENNE CHOMA
- Address
- One Sunset Ave. Montclair NJ US 07042 07042
FDA Registration Numbers#
- 2517506
- 2246703
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DKN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914468 | ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES | Roche Diagnostic Systems, Inc. | 1991-10-30 |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | Hoffmann-La Roche, Inc. | 1983-03-10 |
| K812988 | AGGLUTEX BARBITURATES TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-31 |
Legacy Summary#
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FDA Review#
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