FDA 510(k)
FDA unclassified
Substantially Equivalent
🇬🇧 United Kingdom
RANDOX PHENCYCLIDINE ASSAY
K Number: K043071
·
Decision Jan 27, 2005
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
87
Applicant Total
116
Review Days
80
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Basic Information
- Device Name
- RANDOX PHENCYCLIDINE ASSAY
- K Number
- K043071
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- November 8, 2004
- Decision Date
- January 27, 2005
- Product Code
- LCM
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | FDA unclassified | Unknown |
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