FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SEFRIA PCP Oral Fluid Enzyme Immunoassay
K Number: K203489
·
Decision Apr 20, 2021
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
87
Applicant Total
50
Review Days
144
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Basic Information
- Device Name
- SEFRIA PCP Oral Fluid Enzyme Immunoassay
- K Number
- K203489
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunalysis Corporation
- Date Received
- November 27, 2020
- Decision Date
- April 20, 2021
- 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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Other Clearances by Immunalysis Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252520 | SEFRIA Hydrocodone Oral Fluid | Sep 11, 2025 | Substantially Equivalent |
| K232898 | Quantisal Oral Fluid Collection Device | Nov 21, 2023 | Substantially Equivalent |
| K223781 | Quantisal II Oral Fluid Collection Device | Jul 28, 2023 | Substantially Equivalent |
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | Dec 22, 2021 | Substantially Equivalent |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | Dec 22, 2021 | Substantially Equivalent |
| K200801 | Quantisal Oral Fluid Collection Device | Jul 28, 2020 | Substantially Equivalent |
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | Nov 15, 2019 | Substantially Equivalent |
| K183048 | Quantisal II Oral Fluid Collection Device | Jul 29, 2019 | Substantially Equivalent |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | Jan 24, 2019 | Substantially Equivalent |
| K181553 | Immunalysis Ethyl Alcohol Enzyme Assay | Oct 31, 2018 | Substantially Equivalent |