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FDA 510(k)

ABBOTT A-GENT LIPASE REAGENT

K-Number: K884596 · 1988-12-06

ApplicantAbbott Laboratories
Decision Date1988-12-06
Product CodeCHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT A-GENT LIPASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-12-06 under 510(k) number K884596. 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 ABBOTT A-GENT LIPASE REAGENT?

ABBOTT A-GENT LIPASE REAGENT is a medical device that received FDA 510(k) clearance on 1988-12-06. The listed applicant is Abbott Laboratories. The 510(k) number is K884596.

When did ABBOTT A-GENT LIPASE REAGENT receive FDA 510(k) clearance?

ABBOTT A-GENT LIPASE REAGENT received FDA 510(k) clearance on 1988-12-06, under 510(k) number K884596.

Who is the listed applicant for ABBOTT A-GENT LIPASE REAGENT?

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

What is the FDA product code for ABBOTT A-GENT LIPASE REAGENT?

The FDA product code for ABBOTT A-GENT LIPASE REAGENT is CHI.

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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 COK952816LIPASE FLEX REAGENT CARTRIDGEDupont Medical ProductsK941085LIPASE-PS ASSAY PROCEDURE NO. 805Sigma 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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