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FDA 510(k)

HBF DILUENT

K-Number: K880653 · 1988-04-21

ApplicantHelena Laboratories
Decision Date1988-04-21
Product CodeKQI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HBF DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1988-04-21 under 510(k) number K880653. 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 HBF DILUENT?

HBF DILUENT is a medical device that received FDA 510(k) clearance on 1988-04-21. The listed applicant is Helena Laboratories. The 510(k) number is K880653.

When did HBF DILUENT receive FDA 510(k) clearance?

HBF DILUENT received FDA 510(k) clearance on 1988-04-21, under 510(k) number K880653.

Who is the listed applicant for HBF DILUENT?

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 HBF DILUENT?

The FDA product code for HBF DILUENT 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.

K812226HELENA HBF QUIPLATE CONTROLHelena 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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