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FDA 510(k)

LIPO-SEP CHOLESTEROL AUDIT SYSTEM

K-Number: K812318 · 1981-09-01

ApplicantIsolab, Inc.
Decision Date1981-09-01
Product Code
DecisionSubstantially Equivalent

Device Summary

LIPO-SEP CHOLESTEROL AUDIT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1981-09-01 under 510(k) number K812318. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPO-SEP CHOLESTEROL AUDIT SYSTEM?

LIPO-SEP CHOLESTEROL AUDIT SYSTEM is a medical device that received FDA 510(k) clearance on 1981-09-01. The listed applicant is Isolab, Inc.. The 510(k) number is K812318.

When did LIPO-SEP CHOLESTEROL AUDIT SYSTEM receive FDA 510(k) clearance?

LIPO-SEP CHOLESTEROL AUDIT SYSTEM received FDA 510(k) clearance on 1981-09-01, under 510(k) number K812318.

Who is the listed applicant for LIPO-SEP CHOLESTEROL AUDIT SYSTEM?

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

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Other records listing Isolab, 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.

K951014ISOLAB'S T4 TEST KITK950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITK943547PHENYLALANINE TEST KITK950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEK950415FLUOROSCAN NEONATALK942276QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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