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)

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

K-Number: K192730 · 2020-09-09

ApplicantBiosystems S.A.
Decision Date2020-09-09
Product CodeCHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV is the device name listed in this FDA 510(k) record. The listed applicant is Biosystems S.A.. It received FDA 510(k) clearance on 2020-09-09 under 510(k) number K192730. The device is classified under product code CHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV?

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV is a medical device that received FDA 510(k) clearance on 2020-09-09. The listed applicant is Biosystems S.A.. The 510(k) number is K192730.

When did CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV receive FDA 510(k) clearance?

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV received FDA 510(k) clearance on 2020-09-09, under 510(k) number K192730.

Who is the listed applicant for CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV?

The FDA 510(k) record lists Biosystems S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV?

The FDA product code for CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV is CHW.

Other records listing Biosystems S.A. 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.

K190495TransferrinK182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALK170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

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.

↑