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FDA 510(k)

CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS

K-Number: K952180 · 1995-08-17

ApplicantBeckman Instruments, Inc.
Decision Date1995-08-17
Product CodeCHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1995-08-17 under 510(k) number K952180. 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 CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS?

CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS is a medical device that received FDA 510(k) clearance on 1995-08-17. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K952180.

When did CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS receive FDA 510(k) clearance?

CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS received FDA 510(k) clearance on 1995-08-17, under 510(k) number K952180.

Who is the listed applicant for CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS?

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

What is the FDA product code for CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS?

The FDA product code for CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS is CHI.

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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.K952647IL TEST LIPASEInstrumentation Laboratory COK952816LIPASE FLEX REAGENT CARTRIDGEDupont Medical ProductsK941085LIPASE-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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