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FDA 510(k)

KINETIC AMYLASE DETERMINATION

K-Number: K905651 · 1991-01-31

ApplicantBiochemical Trade, Inc.
Decision Date1991-01-31
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KINETIC AMYLASE DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Trade, Inc.. It received FDA 510(k) clearance on 1991-01-31 under 510(k) number K905651. 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 KINETIC AMYLASE DETERMINATION?

KINETIC AMYLASE DETERMINATION is a medical device that received FDA 510(k) clearance on 1991-01-31. The listed applicant is Biochemical Trade, Inc.. The 510(k) number is K905651.

When did KINETIC AMYLASE DETERMINATION receive FDA 510(k) clearance?

KINETIC AMYLASE DETERMINATION received FDA 510(k) clearance on 1991-01-31, under 510(k) number K905651.

Who is the listed applicant for KINETIC AMYLASE DETERMINATION?

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

What is the FDA product code for KINETIC AMYLASE DETERMINATION?

The FDA product code for KINETIC AMYLASE DETERMINATION is JFJ.

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Other records listing Biochemical Trade, 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.

K942958CREATINE KINASE MB DETERMINATION (UV)K910635TOTAL BILIRUBIN REAGENT SETK910296PHOSPHORUS (INORGANIC) TEST SYSTEMK905776ALBUMIN REAGENT SETK905790TOTAL PROTEIN REAGENT SETK905650KINETIC ALKALINE PHOSPHATASE DETERMINATION

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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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