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FDA 510(k)

BECKMAN EPSILON(TM) LIPASE TEST KIT

K-Number: K864438 · 1987-03-12

ApplicantBeckman Instruments, Inc.
Decision Date1987-03-12
Product CodeCET
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BECKMAN EPSILON(TM) LIPASE TEST KIT 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 1987-03-12 under 510(k) number K864438. The device is classified under product code CET. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN EPSILON(TM) LIPASE TEST KIT?

BECKMAN EPSILON(TM) LIPASE TEST KIT is a medical device that received FDA 510(k) clearance on 1987-03-12. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K864438.

When did BECKMAN EPSILON(TM) LIPASE TEST KIT receive FDA 510(k) clearance?

BECKMAN EPSILON(TM) LIPASE TEST KIT received FDA 510(k) clearance on 1987-03-12, under 510(k) number K864438.

Who is the listed applicant for BECKMAN EPSILON(TM) LIPASE TEST KIT?

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 BECKMAN EPSILON(TM) LIPASE TEST KIT?

The FDA product code for BECKMAN EPSILON(TM) LIPASE TEST KIT is CET.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: CET)

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.

K970124LIPASE REAGENT SET (COLIPASE METHOD)Teco DiagnosticsK940457LIPASE REAGENT SYSTEMMedical Diagnostic Technologies, Inc.K915706LIPASE REAGENT SETTech Intl. Co.K901858MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TESTE.I. Dupont DE Nemours & Co., Inc.K893718DELTATEST (R) LIPASE IIElectro-Nucleonics, Inc.K885078LIPASE SR LIQUID STABLE REAGENT SETMedical Analysis Systems, 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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