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FDA 510(k)

ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS

K-Number: K791373 · 1979-10-26

ApplicantHoffmann-La Roche, Inc.
Decision Date1979-10-26
Product CodeCFE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1979-10-26 under 510(k) number K791373. 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 ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS?

ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS is a medical device that received FDA 510(k) clearance on 1979-10-26. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K791373.

When did ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS receive FDA 510(k) clearance?

ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS received FDA 510(k) clearance on 1979-10-26, under 510(k) number K791373.

Who is the listed applicant for ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS?

The FDA 510(k) record lists Hoffmann-La Roche, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS?

The FDA product code for ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS is CFE.

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Other records listing Hoffmann-La Roche, Inc. 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 KITSebiaK940224CARDIO REP LDHelena LaboratoriesK921455ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHODE.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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