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FDA 510(k)

HEMAFLUOR REAGENT KIT

K-Number: K860309 · 1986-07-14

ApplicantHelena Laboratories
Decision Date1986-07-14
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMAFLUOR REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1986-07-14 under 510(k) number K860309. The device is classified under product code KHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMAFLUOR REAGENT KIT?

HEMAFLUOR REAGENT KIT is a medical device that received FDA 510(k) clearance on 1986-07-14. The listed applicant is Helena Laboratories. The 510(k) number is K860309.

When did HEMAFLUOR REAGENT KIT receive FDA 510(k) clearance?

HEMAFLUOR REAGENT KIT received FDA 510(k) clearance on 1986-07-14, under 510(k) number K860309.

Who is the listed applicant for HEMAFLUOR REAGENT KIT?

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 HEMAFLUOR REAGENT KIT?

The FDA product code for HEMAFLUOR REAGENT KIT is KHO.

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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: KHO)

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.

K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Radiometer Medical ApsK973547TRIAGE STATMETERBiosite IncorporatedK971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.K962919VITROS IMMUNODIAGNOSTIC SYSTEMJohnson & Johnson Clinical Diagnostics, Inc.K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)Biocircuits Corp.K950415FLUOROSCAN NEONATALIsolab, 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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