FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRE-CALIBRATED PIPETTES
K Number: K834100
·
Decision Feb 21, 1984
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
5
Applicant Total
1
Review Days
83
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Basic Information
- Device Name
- PRE-CALIBRATED PIPETTES
- K Number
- K834100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Vitex
- Date Received
- November 30, 1983
- Decision Date
- February 21, 1984
- Product Code
- JRC
- 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 |
|---|---|---|---|
| JRC | Micro Pipette | FDA class 1 | Clinical Chemistry |
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