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FDA 510(k)

LIPASE REAGENT SET (COLIPASE METHOD)

K-Number: K970124 · 1997-03-06

ApplicantTeco Diagnostics
Decision Date1997-03-06
Product CodeCET
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPASE REAGENT SET (COLIPASE METHOD) is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1997-03-06 under 510(k) number K970124. 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 LIPASE REAGENT SET (COLIPASE METHOD)?

LIPASE REAGENT SET (COLIPASE METHOD) is a medical device that received FDA 510(k) clearance on 1997-03-06. The listed applicant is Teco Diagnostics. The 510(k) number is K970124.

When did LIPASE REAGENT SET (COLIPASE METHOD) receive FDA 510(k) clearance?

LIPASE REAGENT SET (COLIPASE METHOD) received FDA 510(k) clearance on 1997-03-06, under 510(k) number K970124.

Who is the listed applicant for LIPASE REAGENT SET (COLIPASE METHOD)?

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

What is the FDA product code for LIPASE REAGENT SET (COLIPASE METHOD)?

The FDA product code for LIPASE REAGENT SET (COLIPASE METHOD) is CET.

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Other records listing Teco Diagnostics 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.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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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.

K940457LIPASE 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.K864438BECKMAN EPSILON(TM) LIPASE TEST KITBeckman Instruments, 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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