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FDA 510(k)

HARLECO BRAND CLINICARD LIPASE TEST SET

K-Number: K791922 · 1979-11-27

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1979-11-27
Product CodeCET
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HARLECO BRAND CLINICARD LIPASE TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-11-27 under 510(k) number K791922. 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 HARLECO BRAND CLINICARD LIPASE TEST SET?

HARLECO BRAND CLINICARD LIPASE TEST SET is a medical device that received FDA 510(k) clearance on 1979-11-27. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K791922.

When did HARLECO BRAND CLINICARD LIPASE TEST SET receive FDA 510(k) clearance?

HARLECO BRAND CLINICARD LIPASE TEST SET received FDA 510(k) clearance on 1979-11-27, under 510(k) number K791922.

Who is the listed applicant for HARLECO BRAND CLINICARD LIPASE TEST SET?

The FDA 510(k) record lists Dade, Baxter Travenol Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARLECO BRAND CLINICARD LIPASE TEST SET?

The FDA product code for HARLECO BRAND CLINICARD LIPASE TEST SET is CET.

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Other records listing Dade, Baxter Travenol Diagnostics, 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.

K800296WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3K792606WHOLE BLOOD PLATELET CONTROL NORMAL,K792723BLOOD FLUID FILTERSK792607T3 UPTAKE (T3U) REAGENTSK792443TSH RADIOIMMUNOASSAYK792442FERRITIN RADIOIMMUNOASSAY

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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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