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FDA 510(k)

EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA

K-Number: K850511 · 1985-02-27

ApplicantMediatech, Inc.
Decision Date1985-02-27
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA is the device name listed in this FDA 510(k) record. The listed applicant is Mediatech, Inc.. It received FDA 510(k) clearance on 1985-02-27 under 510(k) number K850511. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA?

EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA is a medical device that received FDA 510(k) clearance on 1985-02-27. The listed applicant is Mediatech, Inc.. The 510(k) number is K850511.

When did EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA receive FDA 510(k) clearance?

EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA received FDA 510(k) clearance on 1985-02-27, under 510(k) number K850511.

Who is the listed applicant for EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA?

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

What is the FDA product code for EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA?

The FDA product code for EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA is KIT.

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Related Devices (Code: KIT)

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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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