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FDA 510(k)

PARAMAX LIPASE REAGENT

K-Number: K862440 · 1986-08-04

ApplicantAmerican Dade
Decision Date1986-08-04
Product CodeCET
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAMAX LIPASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1986-08-04 under 510(k) number K862440. 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 PARAMAX LIPASE REAGENT?

PARAMAX LIPASE REAGENT is a medical device that received FDA 510(k) clearance on 1986-08-04. The listed applicant is American Dade. The 510(k) number is K862440.

When did PARAMAX LIPASE REAGENT receive FDA 510(k) clearance?

PARAMAX LIPASE REAGENT received FDA 510(k) clearance on 1986-08-04, under 510(k) number K862440.

Who is the listed applicant for PARAMAX LIPASE REAGENT?

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

What is the FDA product code for PARAMAX LIPASE REAGENT?

The FDA product code for PARAMAX LIPASE REAGENT is CET.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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