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FDA 510(k)

AMYLASE

K-Number: K930678 · 1994-04-06

ApplicantHorizon Diagnostics, Inc.
Decision Date1994-04-06
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-04-06 under 510(k) number K930678. 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 AMYLASE?

AMYLASE is a medical device that received FDA 510(k) clearance on 1994-04-06. The listed applicant is Horizon Diagnostics, Inc.. The 510(k) number is K930678.

When did AMYLASE receive FDA 510(k) clearance?

AMYLASE received FDA 510(k) clearance on 1994-04-06, under 510(k) number K930678.

Who is the listed applicant for AMYLASE?

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

What is the FDA product code for AMYLASE?

The FDA product code for AMYLASE is JFJ.

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Other records listing Horizon Diagnostics, 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.

K971566CREATINE KINASE-MB REAGENT SETK933722HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENTK935712IRON/TIBC REAGENTK934533BUN-300/BUN-500 UREA NITROGEN REAGENTK930679DIRECT BILIRUBINK930074IN-VITRO DIAGNOSTIC REAGENT SET

View all 7 devices →

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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