FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
REVISED LABELING FOR TDX PHENCYCLIDINE
K Number: K874484
·
Decision Nov 23, 1987
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
10
Applicant Total
883
Review Days
24
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Basic Information
- Device Name
- REVISED LABELING FOR TDX PHENCYCLIDINE
- K Number
- K874484
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- October 30, 1987
- Decision Date
- November 23, 1987
- Product Code
- LCL
- 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 |
|---|---|---|---|
| LCL | Radioimmunoassay, Phencyclidine | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCL), ordered by most recent decision date.
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PCP DIRECT RIA KIT (I-125)
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ABUSCREEN FP FOR PHENCYCLIDINE
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·Unknown
EMIT HVA PHENCYCLIDINE ASSAY
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FDA Unclassified
·Unknown
REVISED LABELING FOR ADX PHENCYCLIDINE
FDA 510(k)
FDA Unclassified
·Unknown
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