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FDA 510(k)

WIENER LAB AMILASA 405 AA LIQUIDA

K-Number: K023549 · 2002-12-09

ApplicantWiener Laboratories Saic
Decision Date2002-12-09
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WIENER LAB AMILASA 405 AA LIQUIDA is the device name listed in this FDA 510(k) record. The listed applicant is Wiener Laboratories Saic. It received FDA 510(k) clearance on 2002-12-09 under 510(k) number K023549. 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 WIENER LAB AMILASA 405 AA LIQUIDA?

WIENER LAB AMILASA 405 AA LIQUIDA is a medical device that received FDA 510(k) clearance on 2002-12-09. The listed applicant is Wiener Laboratories Saic. The 510(k) number is K023549.

When did WIENER LAB AMILASA 405 AA LIQUIDA receive FDA 510(k) clearance?

WIENER LAB AMILASA 405 AA LIQUIDA received FDA 510(k) clearance on 2002-12-09, under 510(k) number K023549.

Who is the listed applicant for WIENER LAB AMILASA 405 AA LIQUIDA?

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

What is the FDA product code for WIENER LAB AMILASA 405 AA LIQUIDA?

The FDA product code for WIENER LAB AMILASA 405 AA LIQUIDA is JFJ.

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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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