Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Clever Culture Systems AG. It received FDA 510(k) clearance on 2019-05-15 under 510(k) 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. The listed applicant is Clever Culture Systems AG. The 510(k) number is K183648.

When did APAS Independence with Urine Analysis Module receive FDA 510(k) clearance?

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

Who is the listed applicant for APAS Independence with Urine Analysis Module?

The FDA 510(k) record lists Clever Culture Systems AG as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Clever Culture Systems AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200839APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module

Related Devices (Code: PPU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251511PhenoMATRIXCopan Wasp Srl

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.

↑