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In this section: Substantially Equivalent 510(k) Device Information

BK170142: BacT/ALERT BPA Culture Bottle; BacT/ALERT BPN Culture Bottle

510(k) Number: BK170142
Applicant: bioMerieux, Inc.
Device Name: BacT/ALERT® BPA Culture Bottle; BacT/ALERT® BPN Culture Bottle
Decision Date: 2/1/2018

Supporting Documents

BK170142 Letter
BK170142 Summary
The original posted Summary has been replaced with a revised Summary to correct the spelling of BacT/ALERT.
BK170142 Package Insert - BacT/ALERT BPA
BK170142 Package Insert - BacT/ALERT BPN

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