FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABBOTT CATION SUPPLEMENT SOLUTION
K Number: K853546
·
Decision Sep 6, 1985
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
69
Applicant Total
883
Review Days
11
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Basic Information
- Device Name
- ABBOTT CATION SUPPLEMENT SOLUTION
- K Number
- K853546
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2450
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- August 26, 1985
- Decision Date
- September 6, 1985
- Product Code
- JSK
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JSK | Supplement, Culture Media | FDA class 1 | Microbiology |
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