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FDA 510(k)

EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN

K-Number: K850510 · 1985-03-04

ApplicantMediatech, Inc.
Decision Date1985-03-04
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN is the device name listed in this FDA 510(k) record. The listed applicant is Mediatech, Inc.. It received FDA 510(k) clearance on 1985-03-04 under 510(k) number K850510. 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 W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN?

EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN is a medical device that received FDA 510(k) clearance on 1985-03-04. The listed applicant is Mediatech, Inc.. The 510(k) number is K850510.

When did EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN receive FDA 510(k) clearance?

EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN received FDA 510(k) clearance on 1985-03-04, under 510(k) number K850510.

Who is the listed applicant for EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN?

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 W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN?

The FDA product code for EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN is KIT.

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Related Devices (Code: KIT)

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.

K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.

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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