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FDA 510(k)

JAS AMYLASE LIQUID REAGENT

K-Number: K020282 · 2002-02-28

ApplicantJas Diagnostics, Inc.
Decision Date2002-02-28
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

JAS AMYLASE LIQUID REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Jas Diagnostics, Inc.. It received FDA 510(k) clearance on 2002-02-28 under 510(k) number K020282. 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 JAS AMYLASE LIQUID REAGENT?

JAS AMYLASE LIQUID REAGENT is a medical device that received FDA 510(k) clearance on 2002-02-28. The listed applicant is Jas Diagnostics, Inc.. The 510(k) number is K020282.

When did JAS AMYLASE LIQUID REAGENT receive FDA 510(k) clearance?

JAS AMYLASE LIQUID REAGENT received FDA 510(k) clearance on 2002-02-28, under 510(k) number K020282.

Who is the listed applicant for JAS AMYLASE LIQUID REAGENT?

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

What is the FDA product code for JAS AMYLASE LIQUID REAGENT?

The FDA product code for JAS AMYLASE LIQUID REAGENT is JFJ.

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Other records listing Jas 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.

K080623CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NAK080618DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUIDK022519LDL CHOLESTEROL (AUTOMATED)K021671JAS HDL CHOLESTEROL (AUTOMATED) REAGENTK020454CHEMISTRY CALIBRATORK013912CREATINE KINASE (CK-NAC)

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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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