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FDA 510(k)

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

K-Number: K182474 · 2019-05-02

ApplicantBiosystems S.A.
Decision Date2019-05-02
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL is a medical device manufactured by Biosystems S.A.. It received FDA 510(k) clearance on 2019-05-02 under approval number K182474. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL?

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL is a medical device that received FDA 510(k) clearance on 2019-05-02. It is manufactured by Biosystems S.A.. The 510(k) number is K182474.

When was alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL approved by the FDA?

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL received FDA 510(k) clearance on 2019-05-02, under approval number K182474.

What company makes alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL?

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL is manufactured by Biosystems S.A..

What is the FDA product code for alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL?

The FDA product code for alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL is JFJ.

Related Clinical Trials

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Other Devices by Biosystems S.A.

K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 K192730CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV K190495Transferrin

Related Devices (Code: JFJ)

K191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc. K210633Amylase2Abbott Ireland Diagnostics Division

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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