FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS-FP REAGENTS FOR VANCOMYCIN
K Number: K901759
·
Decision May 2, 1990
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
30
Applicant Total
296
Review Days
14
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Basic Information
- Device Name
- COBAS-FP REAGENTS FOR VANCOMYCIN
- K Number
- K901759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3950
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- April 18, 1990
- Decision Date
- May 2, 1990
- Product Code
- LEH
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LEH | Radioimmunoassay, Vancomycin | FDA class 2 | Clinical Toxicology |
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FDA 510(k)
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ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
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IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
FDA 510(k)
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·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 |