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FDA 510(k)

FETAL BOVINE SERUM IN TRANSFER CONTAINER

K-Number: K853441 · 1985-08-26

ApplicantNewport Biosystems, Inc.
Decision Date1985-08-26
Product CodeKJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FETAL BOVINE SERUM IN TRANSFER CONTAINER 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 1985-08-26 under 510(k) number K853441. The device is classified under product code KJA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETAL BOVINE SERUM IN TRANSFER CONTAINER?

FETAL BOVINE SERUM IN TRANSFER CONTAINER is a medical device that received FDA 510(k) clearance on 1985-08-26. The listed applicant is Newport Biosystems, Inc.. The 510(k) number is K853441.

When did FETAL BOVINE SERUM IN TRANSFER CONTAINER receive FDA 510(k) clearance?

FETAL BOVINE SERUM IN TRANSFER CONTAINER received FDA 510(k) clearance on 1985-08-26, under 510(k) number K853441.

Who is the listed applicant for FETAL BOVINE SERUM IN TRANSFER CONTAINER?

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 FETAL BOVINE SERUM IN TRANSFER CONTAINER?

The FDA product code for FETAL BOVINE SERUM IN TRANSFER CONTAINER is KJA.

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 HUMIDIFIERK860282RPMI 1640 W/GLUTAMINE W/HEPESK855085TISSUE CULTURE MEDIA

Related Devices (Code: KJA)

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.

K972404VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)Bd Becton Dickinson Vacutainer Systems PreanalyticK933228KAPTON PEEL POUCHAmerican Fluoroseal Corp.K885121CELL SCRAPERBd Becton Dickinson Vacutainer Systems PreanalyticK873890TISSUE CULTURE FLASKSNunc, Inc.K873889TISSUE CULTURE TUBESNunc, Inc.K871324DU PONT STERICELL CELL CULTURE SYSTEME.I. Dupont DE Nemours & Co., Inc.

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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