FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IDD DETERGENT
K Number: K842070
·
Decision Jul 2, 1984
Classifications
1
FEI Numbers
258
Registration Numbers
258
Same Product Code
15
Applicant Total
4
Review Days
40
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Basic Information
- Device Name
- IDD DETERGENT
- K Number
- K842070
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Interscience Diagnostics, Inc.
- Date Received
- May 23, 1984
- Decision Date
- July 2, 1984
- Product Code
- PPM
- Advisory Committee
- Pathology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| PPM | General Purpose Reagent | FDA class 1 | Pathology |
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