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FDA 510(k)

AMY REAGENT

K-Number: K852001 · 1985-06-10

ApplicantAlpkem Corp.
Decision Date1985-06-10
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMY REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1985-06-10 under 510(k) number K852001. 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 AMY REAGENT?

AMY REAGENT is a medical device that received FDA 510(k) clearance on 1985-06-10. The listed applicant is Alpkem Corp.. The 510(k) number is K852001.

When did AMY REAGENT receive FDA 510(k) clearance?

AMY REAGENT received FDA 510(k) clearance on 1985-06-10, under 510(k) number K852001.

Who is the listed applicant for AMY REAGENT?

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

What is the FDA product code for AMY REAGENT?

The FDA product code for AMY REAGENT is JFJ.

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Other records listing Alpkem Corp. 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.

K894011TOTAL GALACTOSEK891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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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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