FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
K Number: K936131
·
Decision Mar 11, 1994
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
14
Applicant Total
296
Review Days
78
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
- COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
- K Number
- K936131
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- December 23, 1993
- Decision Date
- March 11, 1994
- Product Code
- LGR
- 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 |
|---|---|---|---|
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGR), ordered by most recent decision date.
ACS PHENYTOIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INNOFLUOR PHENYTOIN ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AXSYM PHENYTOIN II
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TDX(R)/TDXFLX(R) PHENYTOIN II
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AXSYM PHENYTOIN ASSAY
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 |
| 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 |