FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
K Number: K961726
·
Decision Jul 11, 1996
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
122
Applicant Total
296
Review Days
69
Basic Information
- Device Name
- ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
- K Number
- K961726
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3200
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- Date Received
- May 3, 1996
- Decision Date
- July 11, 1996
- Product Code
- DLJ
- 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 |
|---|---|---|---|
| DLJ | Calibrators, Drug Specific | FDA class 2 | Clinical Toxicology |
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Other Clearances by ROCHE DIAGNOSTIC SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | May 3, 1999 | Substantially Equivalent |
| 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 |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | Dec 11, 1998 | Substantially Equivalent |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | 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 |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | Dec 11, 1998 | Substantially Equivalent |