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FDA 510(k)

MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658

K-Number: K011145 · 2001-06-25

ApplicantRoche Diagnostics Corp.
Decision Date2001-06-25
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2001-06-25 under 510(k) number K011145. 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 MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658?

MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 is a medical device that received FDA 510(k) clearance on 2001-06-25. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K011145.

When did MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 receive FDA 510(k) clearance?

MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 received FDA 510(k) clearance on 2001-06-25, under 510(k) number K011145.

Who is the listed applicant for MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658?

The FDA product code for MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 is JFJ.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: JFJ)

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.

K210633Amylase2Abbott Ireland Diagnostics DivisionK191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALBiosystems S.A.K130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYHitachi Chemical Diagnostics, Inc.K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroupK091846SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607Beckman Coulter, Inc.

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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