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FDA 510(k)

INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)

K-Number: K001569 · 2000-06-26

ApplicantSigma Diagnostics, Inc.
Decision Date2000-06-26
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 2000-06-26 under 510(k) number K001569. 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 INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)?

INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) is a medical device that received FDA 510(k) clearance on 2000-06-26. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K001569.

When did INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) receive FDA 510(k) clearance?

INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) received FDA 510(k) clearance on 2000-06-26, under 510(k) number K001569.

Who is the listed applicant for INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)?

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

What is the FDA product code for INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)?

The FDA product code for INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) is JFJ.

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Other records listing Sigma Diagnostics, Inc. 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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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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