FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DETECTION SYSTEM, MS-2 ELECTROCHEMICAL
K Number: K790297
·
Decision Apr 26, 1979
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
10
Applicant Total
883
Review Days
76
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Basic Information
- Device Name
- DETECTION SYSTEM, MS-2 ELECTROCHEMICAL
- K Number
- K790297
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- February 9, 1979
- Decision Date
- April 26, 1979
- Product Code
- JTA
- 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 |
|---|---|---|---|
| JTA | Monitor, Microbial Growth | FDA class 1 | Microbiology |
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