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FDA 510(k)

COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL

K-Number: K923318 · 1992-08-25

ApplicantHelena Laboratories
Decision Date1992-08-25
Product CodeJPD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1992-08-25 under 510(k) number K923318. The device is classified under product code JPD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL?

COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL is a medical device that received FDA 510(k) clearance on 1992-08-25. The listed applicant is Helena Laboratories. The 510(k) number is K923318.

When did COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL receive FDA 510(k) clearance?

COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL received FDA 510(k) clearance on 1992-08-25, under 510(k) number K923318.

Who is the listed applicant for COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL?

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 COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL?

The FDA product code for COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL is JPD.

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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: JPD)

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.

K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODETosoh Medics, Inc.K991127VARIANT II B-THALASSEMIABio-RadK924122VARIANT BETA-THALASSEMIA SHORT PROGRAMBio-RadK924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITDrew Scientific , Ltd.K923317COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMALHelena LaboratoriesK913384COLUMNMATE(TM) BETA-THAL CAT. NO. 4515Helena 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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