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FDA 510(k)

RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)

K-Number: K871269 · 1987-04-13

ApplicantTechnicon Instruments Corp.
Decision Date1987-04-13
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1987-04-13 under 510(k) number K871269. 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 RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)?

RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) is a medical device that received FDA 510(k) clearance on 1987-04-13. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K871269.

When did RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) receive FDA 510(k) clearance?

RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) received FDA 510(k) clearance on 1987-04-13, under 510(k) number K871269.

Who is the listed applicant for RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)?

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

What is the FDA product code for RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)?

The FDA product code for RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) 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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