FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTH IRMA KIT MITSUBISHI YUKA
K Number: K910178
·
Decision May 22, 1991
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
29
Applicant Total
2
Review Days
127
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Basic Information
- Device Name
- ACTH IRMA KIT MITSUBISHI YUKA
- K Number
- K910178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1025
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Science Regulatory Services Intl.
- Date Received
- January 15, 1991
- Decision Date
- May 22, 1991
- Product Code
- CKG
- 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 |
|---|---|---|---|
| CKG | Radioimmunoassay, Acth | FDA class 2 | Clinical Chemistry |
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Other Clearances by Science Regulatory Services Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K895137 | DIOTHERM | Nov 16, 1990 | Substantially Equivalent |