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FDA 510(k)

SICKLE-CELL F TEST

K-Number: K791143 · 1979-07-17

ApplicantIsolab, Inc.
Decision Date1979-07-17
Product CodeKQI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SICKLE-CELL F TEST is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1979-07-17 under 510(k) number K791143. The device is classified under product code KQI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SICKLE-CELL F TEST?

SICKLE-CELL F TEST is a medical device that received FDA 510(k) clearance on 1979-07-17. The listed applicant is Isolab, Inc.. The 510(k) number is K791143.

When did SICKLE-CELL F TEST receive FDA 510(k) clearance?

SICKLE-CELL F TEST received FDA 510(k) clearance on 1979-07-17, under 510(k) number K791143.

Who is the listed applicant for SICKLE-CELL F TEST?

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 SICKLE-CELL F TEST?

The FDA product code for SICKLE-CELL F TEST is KQI.

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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: KQI)

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.

K880653HBF DILUENTHelena LaboratoriesK812226HELENA HBF QUIPLATE CONTROLHelena LaboratoriesK810475HELENA HEMOGLOBIN F CONTROLSHelena Laboratories

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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