510(k) K192665
- Device
- Accelerate Pheno System, Accelerate PhenoTest BC Kit
- Applicant
- Accelerate Diagnostics, Inc.
- 510(k) number
- K192665
- Product code
- PRH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-09-15
- Date received
- 2019-09-25
- Regulation
- 866.1650
- Classification name
- Positive Blood Culture Identification And Ast Kit
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Carrene Plummer
- Address
- 3950 S. Country Club Rd. #470 Tucson AZ US 85714 85714
Source Documents#
Other 510(k) Records For Product Code PRH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC Kit | Accelerate Diagnotics | 2017-02-23 |
Legacy Summary#
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FDA Review#
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