FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311
K Number: K922770
·
Decision Aug 18, 1992
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
3
Review Days
70
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Basic Information
- Device Name
- UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311
- K Number
- K922770
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1113
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Leica, Inc.
- Date Received
- June 9, 1992
- Decision Date
- August 18, 1992
- Product Code
- MQM
- 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 |
|---|---|---|---|
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | FDA class 1 | Clinical Chemistry |
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