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FDA 510(k)

CARDIO REP LD

K-Number: K940224 · 1994-08-17

ApplicantHelena Laboratories
Decision Date1994-08-17
Product CodeCFE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIO REP LD is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1994-08-17 under 510(k) number K940224. The device is classified under product code CFE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO REP LD?

CARDIO REP LD is a medical device that received FDA 510(k) clearance on 1994-08-17. The listed applicant is Helena Laboratories. The 510(k) number is K940224.

When did CARDIO REP LD receive FDA 510(k) clearance?

CARDIO REP LD received FDA 510(k) clearance on 1994-08-17, under 510(k) number K940224.

Who is the listed applicant for CARDIO REP LD?

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 CARDIO REP LD?

The FDA product code for CARDIO REP LD is CFE.

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Other records listing Helena Laboratories as applicant

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Related Devices (Code: CFE)

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.

K100307GELSCAN, MODEL 1206SebiaK022455SPIFE LD-12 KIT, MODEL 3338Helena LaboratoriesK020467SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452Helena LaboratoriesK970477HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KITSebiaK921455ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHODE.I. Dupont DE Nemours & Co., Inc.K905861ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METHE.I. Dupont DE Nemours & Co., 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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