510(k) K200204
- Device
- Stat Profile Prime Plus Analyzer System
- Applicant
- Nova Biomedical Corporation
- 510(k) number
- K200204
- Product code
- GGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-04-06
- Date received
- 2020-01-28
- Regulation
- 864.7500
- Classification name
- Oxyhemoglobin
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rachel Gilbert
- Address
- 200 Prospect St. Walham MA US 02454 02454
FDA Registration Numbers#
- 1219029
- 9610126
- 3023162659
- 3006198300
- 3003795116
Source Documents#
Other 510(k) Records For Product Code GGZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180186 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-08-23 |
Legacy Summary#
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FDA Review#
Decision Summary