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FDA 510(k)

RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640

K-Number: K850513 · 1985-02-27

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

Device Summary

RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640 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 K850513. 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 RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640?

RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640 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 K850513.

When did RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640 receive FDA 510(k) clearance?

RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640 received FDA 510(k) clearance on 1985-02-27, under 510(k) number K850513.

Who is the listed applicant for RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640?

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 RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640?

The FDA product code for RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640 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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