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FDA 510(k)

RPMI 1640 W/GLUTAMINE W/HEPES

K-Number: K860282 · 1986-02-05

ApplicantNewport Biosystems, Inc.
Decision Date1986-02-05
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RPMI 1640 W/GLUTAMINE W/HEPES 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 1986-02-05 under 510(k) number K860282. 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 W/GLUTAMINE W/HEPES?

RPMI 1640 W/GLUTAMINE W/HEPES is a medical device that received FDA 510(k) clearance on 1986-02-05. The listed applicant is Newport Biosystems, Inc.. The 510(k) number is K860282.

When did RPMI 1640 W/GLUTAMINE W/HEPES receive FDA 510(k) clearance?

RPMI 1640 W/GLUTAMINE W/HEPES received FDA 510(k) clearance on 1986-02-05, under 510(k) number K860282.

Who is the listed applicant for RPMI 1640 W/GLUTAMINE W/HEPES?

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 RPMI 1640 W/GLUTAMINE W/HEPES?

The FDA product code for RPMI 1640 W/GLUTAMINE W/HEPES is KIT.

Related Clinical Trials

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.

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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 HUMIDIFIERK855085TISSUE CULTURE MEDIAK853441FETAL 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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