FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
K Number: K151348
·
Decision Aug 18, 2015
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
20
Applicant Total
27
Review Days
90
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Basic Information
- Device Name
- Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
- K Number
- K151348
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3910
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healgen Scientific,, LLC
- Date Received
- May 20, 2015
- Decision Date
- August 18, 2015
- Product Code
- LFG
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | FDA class 2 | Clinical Toxicology |
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