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FDA 510(k)

ULTRAZYME PLUS AMYL

K-Number: K821869 · 1982-07-13

ApplicantHarleco Diagnostics
Decision Date1982-07-13
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS AMYL is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1982-07-13 under 510(k) number K821869. 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 ULTRAZYME PLUS AMYL?

ULTRAZYME PLUS AMYL is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Harleco Diagnostics. The 510(k) number is K821869.

When did ULTRAZYME PLUS AMYL receive FDA 510(k) clearance?

ULTRAZYME PLUS AMYL received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821869.

Who is the listed applicant for ULTRAZYME PLUS AMYL?

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

What is the FDA product code for ULTRAZYME PLUS AMYL?

The FDA product code for ULTRAZYME PLUS AMYL is JFJ.

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Other records listing Harleco Diagnostics 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.

K823147URIC ACID STANDARD, 8MG/DL #65078K822852TRIGLYCERIDE CALIBRATORK822323ULTRACHEM BUN-UV, 65080 & 65081K821880ULTRA CHEM ALBK821877ULTRAZYME PLUS HBDK821879ULTRACHEM T.P.

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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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