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FDA 510(k)

CLINICARD UV AMYLASE CHEMISTRY

K-Number: K771131 · 1977-07-21

ApplicantHarleco
Decision Date1977-07-21
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINICARD UV AMYLASE CHEMISTRY is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-07-21 under 510(k) number K771131. 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 CLINICARD UV AMYLASE CHEMISTRY?

CLINICARD UV AMYLASE CHEMISTRY is a medical device that received FDA 510(k) clearance on 1977-07-21. The listed applicant is Harleco. The 510(k) number is K771131.

When did CLINICARD UV AMYLASE CHEMISTRY receive FDA 510(k) clearance?

CLINICARD UV AMYLASE CHEMISTRY received FDA 510(k) clearance on 1977-07-21, under 510(k) number K771131.

Who is the listed applicant for CLINICARD UV AMYLASE CHEMISTRY?

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

What is the FDA product code for CLINICARD UV AMYLASE CHEMISTRY?

The FDA product code for CLINICARD UV AMYLASE CHEMISTRY is JFJ.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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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