FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
K Number: K011730
·
Decision Aug 9, 2001
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
87
Applicant Total
85
Review Days
65
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Basic Information
- Device Name
- ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
- K Number
- K011730
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- June 5, 2001
- Decision Date
- August 9, 2001
- Product Code
- LCM
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | FDA unclassified | Unknown |
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