510(k) K812988
- Device
- AGGLUTEX BARBITURATES TEST KIT
- Applicant
- HOFFMANN-LA ROCHE, INC.
- 510(k) number
- K812988
- Product code
- DKN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-12-31
- Date received
- 1981-10-26
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K881816 | ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES | Roche Diagnostic Systems, Inc. | 1988-07-28 |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | Hoffmann-La Roche, Inc. | 1983-03-10 |
Legacy Summary#
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FDA Review#
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