FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
K Number: K983697
·
Decision Dec 11, 1998
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
296
Review Days
51
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
- K Number
- K983697
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- October 21, 1998
- Decision Date
- December 11, 1998
- Product Code
- DIO
- 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIO), ordered by most recent decision date.
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRI Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRI Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Emit II Plus Cocaine Metabolite Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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 |
| 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 |