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FDA 510(k)

APAS Independence with Urine Analysis Module

K-Number: K183648 · 2019-05-15

ApplicantClever Culture Systems AG
Decision Date2019-05-15
Product CodePPU
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

APAS Independence with Urine Analysis Module is a medical device manufactured by Clever Culture Systems AG. It received FDA 510(k) clearance on 2019-05-15 under approval number K183648. The device is classified under product code PPU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APAS Independence with Urine Analysis Module?

APAS Independence with Urine Analysis Module is a medical device that received FDA 510(k) clearance on 2019-05-15. It is manufactured by Clever Culture Systems AG. The 510(k) number is K183648.

When was APAS Independence with Urine Analysis Module approved by the FDA?

APAS Independence with Urine Analysis Module received FDA 510(k) clearance on 2019-05-15, under approval number K183648.

What company makes APAS Independence with Urine Analysis Module?

APAS Independence with Urine Analysis Module is manufactured by Clever Culture Systems AG.

What is the FDA product code for APAS Independence with Urine Analysis Module?

The FDA product code for APAS Independence with Urine Analysis Module is PPU.

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Other Devices by Clever Culture Systems AG

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Related Devices (Code: PPU)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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