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FDA 510(k)

COLUMNMATE(TM) BETA-THAL CAT. NO. 4515

K-Number: K913384 · 1991-12-17

ApplicantHelena Laboratories
Decision Date1991-12-17
Product CodeJPD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1991-12-17 under 510(k) number K913384. 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(TM) BETA-THAL CAT. NO. 4515?

COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 is a medical device that received FDA 510(k) clearance on 1991-12-17. The listed applicant is Helena Laboratories. The 510(k) number is K913384.

When did COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 receive FDA 510(k) clearance?

COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 received FDA 510(k) clearance on 1991-12-17, under 510(k) number K913384.

Who is the listed applicant for COLUMNMATE(TM) BETA-THAL CAT. NO. 4515?

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(TM) BETA-THAL CAT. NO. 4515?

The FDA product code for COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 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.K923318COLUMNMATE BETA-THAL HBA2 CONTROL - NORMALHelena LaboratoriesK923317COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMALHelena 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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