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FDA 510(k)

HELENA HBF QUIPLATE CONTROL

K-Number: K812226 · 1981-09-01

ApplicantHelena Laboratories
Decision Date1981-09-01
Product CodeKQI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HELENA HBF QUIPLATE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1981-09-01 under 510(k) number K812226. 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 HBF QUIPLATE CONTROL?

HELENA HBF QUIPLATE CONTROL is a medical device that received FDA 510(k) clearance on 1981-09-01. The listed applicant is Helena Laboratories. The 510(k) number is K812226.

When did HELENA HBF QUIPLATE CONTROL receive FDA 510(k) clearance?

HELENA HBF QUIPLATE CONTROL received FDA 510(k) clearance on 1981-09-01, under 510(k) number K812226.

Who is the listed applicant for HELENA HBF QUIPLATE CONTROL?

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 HBF QUIPLATE CONTROL?

The FDA product code for HELENA HBF QUIPLATE CONTROL 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 LaboratoriesK810475HELENA HEMOGLOBIN F CONTROLSHelena 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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