FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
K Number: K142280
·
Decision Oct 16, 2014
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
27
Review Days
62
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Basic Information
- Device Name
- Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
- K Number
- K142280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healgen Scientific,, LLC
- Date Received
- August 15, 2014
- Decision Date
- October 16, 2014
- Product Code
- DJG
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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|---|---|---|---|
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| K251800 | Healgen® URS Test Strips | Dec 23, 2025 | Substantially Equivalent |
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| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Aug 15, 2025 | Substantially Equivalent |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | Dec 17, 2024 | Substantially Equivalent |
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| K232377 | Healgen Rapid COVID-19 Antigen Test | Apr 19, 2024 | Substantially Equivalent |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Apr 12, 2024 | Substantially Equivalent |