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FDA 510(k)

LIPASE DETERMINATION

K-Number: K800550 · 1980-04-02

ApplicantThe Dow Chemical Co.
Decision Date1980-04-02
Product CodeCFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPASE DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is The Dow Chemical Co.. It received FDA 510(k) clearance on 1980-04-02 under 510(k) number K800550. The device is classified under product code CFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPASE DETERMINATION?

LIPASE DETERMINATION is a medical device that received FDA 510(k) clearance on 1980-04-02. The listed applicant is The Dow Chemical Co.. The 510(k) number is K800550.

When did LIPASE DETERMINATION receive FDA 510(k) clearance?

LIPASE DETERMINATION received FDA 510(k) clearance on 1980-04-02, under 510(k) number K800550.

Who is the listed applicant for LIPASE DETERMINATION?

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

What is the FDA product code for LIPASE DETERMINATION?

The FDA product code for LIPASE DETERMINATION is CFG.

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Other records listing The Dow Chemical Co. 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.

K823474ENZYMATIC GLUCOSE DETERMINATIONK822154UREA NITROGEN (ENZYMATIC) DETERMINATIONK821536DOWFLOW ALT-UV DETERMINATIONK821315DOWFLOW ENZYMATIC TRIGLYCERIDES DETERMK820675BILIRUBIN(TOTAL) DETERMINATION CTMSK820714DOW BILIRUBIN(DIRECT) DETERMINATION

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Related Devices (Code: CFG)

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.

K860554SERUM LIPASE REAGENT SET (TURBIDIMETRIC)Sterling 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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