FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K Number: K983698
·
Decision May 3, 1999
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
99
Applicant Total
296
Review Days
194
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Basic Information
- Device Name
- MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
- K Number
- K983698
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- October 21, 1998
- Decision Date
- May 3, 1999
- Product Code
- DIS
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DIS | Enzyme Immunoassay, Barbiturate | FDA class 2 | Clinical Toxicology |
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Other Clearances by Roche Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983702 | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES | Feb 11, 1999 | Substantially Equivalent |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | Feb 10, 1999 | Substantially Equivalent |
| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | Dec 15, 1998 | Substantially Equivalent |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | Dec 15, 1998 | Substantially Equivalent |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | Dec 11, 1998 | Substantially Equivalent |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | Dec 11, 1998 | Substantially Equivalent |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | Dec 11, 1998 | Substantially Equivalent |
| K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | Dec 11, 1998 | Substantially Equivalent |
| K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | Dec 11, 1998 | Substantially Equivalent |
| K983174 | ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES | Nov 18, 1998 | Substantially Equivalent |