FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
K Number: K121231
·
Decision Jul 30, 2012
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
39
Applicant Total
1
Review Days
97
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Basic Information
- Device Name
- IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
- K Number
- K121231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ind Ndiagnostic, Inc.
- Date Received
- April 24, 2012
- Decision Date
- July 30, 2012
- Product Code
- NGT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| NGT | Saline, Vascular Access Flush | FDA class 2 | General Hospital |
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