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FDA 510(k)

ROTAZYME

K-Number: K791746 · 1979-11-16

ApplicantAbbott Laboratories
Decision Date1979-11-16
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROTAZYME is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1979-11-16 under 510(k) number K791746. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTAZYME?

ROTAZYME is a medical device that received FDA 510(k) clearance on 1979-11-16. The listed applicant is Abbott Laboratories. The 510(k) number is K791746.

When did ROTAZYME receive FDA 510(k) clearance?

ROTAZYME received FDA 510(k) clearance on 1979-11-16, under 510(k) number K791746.

Who is the listed applicant for ROTAZYME?

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

What is the FDA product code for ROTAZYME?

The FDA product code for ROTAZYME is LFX.

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Related Devices (Code: LFX)

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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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