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FDA 510(k)

GENZYME A-AMYLASE TEST REAGENT

K-Number: K933397 · 1993-10-28

ApplicantGenzyme Corp.
Decision Date1993-10-28
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENZYME A-AMYLASE TEST REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 1993-10-28 under 510(k) number K933397. 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 GENZYME A-AMYLASE TEST REAGENT?

GENZYME A-AMYLASE TEST REAGENT is a medical device that received FDA 510(k) clearance on 1993-10-28. The listed applicant is Genzyme Corp.. The 510(k) number is K933397.

When did GENZYME A-AMYLASE TEST REAGENT receive FDA 510(k) clearance?

GENZYME A-AMYLASE TEST REAGENT received FDA 510(k) clearance on 1993-10-28, under 510(k) number K933397.

Who is the listed applicant for GENZYME A-AMYLASE TEST REAGENT?

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

What is the FDA product code for GENZYME A-AMYLASE TEST REAGENT?

The FDA product code for GENZYME A-AMYLASE TEST REAGENT is JFJ.

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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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