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FDA 510(k)

TISSUE CULTURE FLASK

K-Number: K864021 · 1986-10-29

ApplicantFenwal Laboratories
Decision Date1986-10-29
Product CodeKJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TISSUE CULTURE FLASK is the device name listed in this FDA 510(k) record. The listed applicant is Fenwal Laboratories. It received FDA 510(k) clearance on 1986-10-29 under 510(k) number K864021. 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 TISSUE CULTURE FLASK?

TISSUE CULTURE FLASK is a medical device that received FDA 510(k) clearance on 1986-10-29. The listed applicant is Fenwal Laboratories. The 510(k) number is K864021.

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

TISSUE CULTURE FLASK received FDA 510(k) clearance on 1986-10-29, under 510(k) number K864021.

Who is the listed applicant for TISSUE CULTURE FLASK?

The FDA 510(k) record lists Fenwal Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TISSUE CULTURE FLASK?

The FDA product code for TISSUE CULTURE FLASK is KJA.

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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

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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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