FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS-FP REAGENTS AND CALIBRATORS
K Number: K941712
·
Decision Jun 13, 1994
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
296
Review Days
68
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Basic Information
- Device Name
- COBAS-FP REAGENTS AND CALIBRATORS
- K Number
- K941712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3035
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- April 6, 1994
- Decision Date
- June 13, 1994
- Product Code
- LGJ
- 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 |
|---|---|---|---|
| LGJ | Fluorescence Polarization Immunoassay, Amibacin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGJ), ordered by most recent decision date.
COBAS INTEGRA AMIKACIN MAB
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AMIKACIN KIT (FPIA)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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|---|---|---|---|
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| 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 |