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FDA 510(k)

TISSUE CULTURE MEDIA

K-Number: K855085 · 1986-01-13

ApplicantNewport Biosystems, Inc.
Decision Date1986-01-13
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TISSUE CULTURE MEDIA is the device name listed in this FDA 510(k) record. The listed applicant is Newport Biosystems, Inc.. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K855085. 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 TISSUE CULTURE MEDIA?

TISSUE CULTURE MEDIA is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is Newport Biosystems, Inc.. The 510(k) number is K855085.

When did TISSUE CULTURE MEDIA receive FDA 510(k) clearance?

TISSUE CULTURE MEDIA received FDA 510(k) clearance on 1986-01-13, under 510(k) number K855085.

Who is the listed applicant for TISSUE CULTURE MEDIA?

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

What is the FDA product code for TISSUE CULTURE MEDIA?

The FDA product code for TISSUE CULTURE MEDIA is KIT.

Related Clinical Trials

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Other records listing Newport Biosystems, Inc. as applicant

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.

K881648TRANSFER CONTAINER HUMIDIFIERK860282RPMI 1640 W/GLUTAMINE W/HEPESK853441FETAL BOVINE SERUM IN TRANSFER CONTAINER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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