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FDA 510(k)

LIPASE FLEX REAGENT CARTRIDGE

K-Number: K952816 · 1995-07-20

ApplicantDupont Medical Products
Decision Date1995-07-20
Product CodeCHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPASE FLEX REAGENT CARTRIDGE 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 1995-07-20 under 510(k) number K952816. The device is classified under product code CHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPASE FLEX REAGENT CARTRIDGE?

LIPASE FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1995-07-20. The listed applicant is Dupont Medical Products. The 510(k) number is K952816.

When did LIPASE FLEX REAGENT CARTRIDGE receive FDA 510(k) clearance?

LIPASE FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 1995-07-20, under 510(k) number K952816.

Who is the listed applicant for LIPASE FLEX REAGENT CARTRIDGE?

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 LIPASE FLEX REAGENT CARTRIDGE?

The FDA product code for LIPASE FLEX REAGENT CARTRIDGE is CHI.

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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 METHODK952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROLK945280DUPONT DIMENSION C-REACTIVE PROTEIN METHODK944932PHENOBARBITAL FLEX REAGENT CARTRIDGEK941050DUPONT ACA STAR

View all 28 devices →

Related Devices (Code: CHI)

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.

K970905SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENTBeckman Instruments, Inc.K961179SENTINEL LIPASE LIQUID MODEL 17.401BEqual Diagnostics, Inc.K952180CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMSBeckman Instruments, Inc.K952647IL TEST LIPASEInstrumentation Laboratory COK941085LIPASE-PS ASSAY PROCEDURE NO. 805Sigma Diagnostics, Inc.K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYNuclear Diagnostics, 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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