FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROLYTE 7
K Number: K880973
·
Decision Sep 7, 1988
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
28
Applicant Total
3
Review Days
183
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Basic Information
- Device Name
- MICROLYTE 7
- K Number
- K880973
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- The Rupp & Bowman Co.
- Date Received
- March 8, 1988
- Decision Date
- September 7, 1988
- Product Code
- JFP
- 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 |
|---|---|---|---|
| JFP | Electrode, Ion Specific, Calcium | FDA class 2 | Clinical Chemistry |
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