Product code JQP
- Device name
- Calculator/Data Processing Module, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2100
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
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| K854265 | SIMULATOR | Cygnus of South Florida, Inc. | 1986-03-18 |
| K853026 | BIOVATION MAX DATA MANAGEMENT SYSTEM | Biovation, Inc. | 1985-08-02 |
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| K843365 | ISO-DATA IMMUNOASSAY NETWORK SYSTEM | Iso-Data, Inc. | 1984-09-27 |
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| K833353 | ACLAIM-QAP IBM PERSONAL COMPUTER EDT | American Dade | 1983-12-22 |
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