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FDA 510(k)

HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT

K-Number: K970477 · 1997-03-10

ApplicantSebia
Decision Date1997-03-10
Product CodeCFE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 1997-03-10 under 510(k) number K970477. 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 HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT?

HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT is a medical device that received FDA 510(k) clearance on 1997-03-10. The listed applicant is Sebia. The 510(k) number is K970477.

When did HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT receive FDA 510(k) clearance?

HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT received FDA 510(k) clearance on 1997-03-10, under 510(k) number K970477.

Who is the listed applicant for HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT?

The FDA 510(k) record lists Sebia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT?

The FDA product code for HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT is CFE.

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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 LaboratoriesK940224CARDIO REP LDHelena LaboratoriesK921455ACA 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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