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FDA 510(k)

DUPONT DIMENSION AMYLASE METHOD

K-Number: K942640 · 1994-09-09

ApplicantDupont Medical Products
Decision Date1994-09-09
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DUPONT DIMENSION AMYLASE METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Dupont Medical Products. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K942640. 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 DUPONT DIMENSION AMYLASE METHOD?

DUPONT DIMENSION AMYLASE METHOD is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Dupont Medical Products. The 510(k) number is K942640.

When did DUPONT DIMENSION AMYLASE METHOD receive FDA 510(k) clearance?

DUPONT DIMENSION AMYLASE METHOD received FDA 510(k) clearance on 1994-09-09, under 510(k) number K942640.

Who is the listed applicant for DUPONT DIMENSION AMYLASE METHOD?

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

What is the FDA product code for DUPONT DIMENSION AMYLASE METHOD?

The FDA product code for DUPONT DIMENSION AMYLASE METHOD is JFJ.

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Other records listing Dupont Medical Products 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.

K952815DUPONT LIPASE CALIBRATORK950920DUPONT DIMENSION TOTAL PROTEIN METHODK952816LIPASE FLEX REAGENT CARTRIDGEK952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROLK945280DUPONT DIMENSION C-REACTIVE PROTEIN METHODK944932PHENOBARBITAL FLEX REAGENT CARTRIDGE

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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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