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FDA 510(k)

HELENA HEMOGLOBIN F CONTROLS

K-Number: K810475 · 1981-03-26

ApplicantHelena Laboratories
Decision Date1981-03-26
Product CodeKQI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HELENA HEMOGLOBIN F CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1981-03-26 under 510(k) number K810475. 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 HELENA HEMOGLOBIN F CONTROLS?

HELENA HEMOGLOBIN F CONTROLS is a medical device that received FDA 510(k) clearance on 1981-03-26. The listed applicant is Helena Laboratories. The 510(k) number is K810475.

When did HELENA HEMOGLOBIN F CONTROLS receive FDA 510(k) clearance?

HELENA HEMOGLOBIN F CONTROLS received FDA 510(k) clearance on 1981-03-26, under 510(k) number K810475.

Who is the listed applicant for HELENA HEMOGLOBIN F CONTROLS?

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

What is the FDA product code for HELENA HEMOGLOBIN F CONTROLS?

The FDA product code for HELENA HEMOGLOBIN F CONTROLS is KQI.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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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 LaboratoriesK791143SICKLE-CELL F TESTIsolab, 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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