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FDA 510(k)

AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10

K-Number: K974053 · 1997-12-08

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1997-12-08
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1997-12-08 under 510(k) number K974053. 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 AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10?

AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 is a medical device that received FDA 510(k) clearance on 1997-12-08. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K974053.

When did AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 receive FDA 510(k) clearance?

AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 received FDA 510(k) clearance on 1997-12-08, under 510(k) number K974053.

Who is the listed applicant for AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10?

The FDA product code for AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 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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