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FDA 510(k)

QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY

K-Number: K942276 · 1995-01-20

ApplicantIsolab, Inc.
Decision Date1995-01-20
Product CodeGIQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1995-01-20 under 510(k) number K942276. The device is classified under product code GIQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY?

QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is Isolab, Inc.. The 510(k) number is K942276.

When did QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY receive FDA 510(k) clearance?

QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY received FDA 510(k) clearance on 1995-01-20, under 510(k) number K942276.

Who is the listed applicant for QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY?

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

What is the FDA product code for QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY?

The FDA product code for QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY is GIQ.

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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 NEONATALK942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS

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Related Devices (Code: GIQ)

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.

K955719SICKLE-2000Medicus Technologies, Inc.K874429HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12Hf Scientific, 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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