FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARMTROL AND FERMTROL
K Number: K780802
·
Decision Jun 13, 1978
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
5
Review Days
33
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Basic Information
- Device Name
- ARMTROL AND FERMTROL
- K Number
- K780802
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biotron , Ltd.
- Date Received
- May 11, 1978
- Decision Date
- June 13, 1978
- Product Code
- JJW
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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