FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
REVISED LABELING FOR ADX PHENCYCLIDINE
K Number: K880011
·
Decision Feb 11, 1988
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
10
Applicant Total
883
Review Days
38
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- REVISED LABELING FOR ADX PHENCYCLIDINE
- K Number
- K880011
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- January 4, 1988
- Decision Date
- February 11, 1988
- 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.
PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY
FDA 510(k)
FDA Unclassified
·Unknown
AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C
FDA 510(k)
FDA Unclassified
·Unknown
PCP DIRECT RIA KIT (I-125)
FDA 510(k)
FDA Unclassified
·Unknown
ABUSCREEN FP FOR PHENCYCLIDINE
FDA 510(k)
FDA Unclassified
·Unknown
EMIT HVA PHENCYCLIDINE ASSAY
FDA 510(k)
FDA Unclassified
·Unknown
REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Abbott Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K252424 | Anti-HCV Next | Apr 28, 2026 | Substantially Equivalent |
| K243500 | ARCHITECT iGentamicin | Jul 9, 2025 | Substantially Equivalent |
| K243168 | Alinity i Rubella IgG | Jun 20, 2025 | Substantially Equivalent |
| K243283 | Alinity h-series System | Feb 20, 2025 | Substantially Equivalent |
| K233932 | Alinity i Toxo IgM | Aug 30, 2024 | Substantially Equivalent |
| K232669 | TBI | Sep 29, 2023 | Substantially Equivalent |
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K220031 | Alinity h-series System | Aug 4, 2023 | Substantially Equivalent |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Jul 14, 2023 | Substantially Equivalent |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Jun 5, 2023 | Substantially Equivalent |