510(k) BK110039
- Device
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- Applicant
- Life Technologies Corporation
- 510(k) number
- BK110039
- Product code
- PCA
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2013-02-05
- Date received
- 2011-08-02
- Regulation
- 862.2570
- Classification name
- Dna Genetic Analyzer
- Medical specialty
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- Review panel
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- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code PCA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191030 | Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer | Life Technologies Corporation | 2020-02-21 |
Legacy Summary#
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FDA Review#
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