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FDA 510(k)

TISSUE CULTURE BAG

K-Number: K870865 · 1987-03-30

ApplicantAmerican Fluoroseal Corp.
Decision Date1987-03-30
Product CodeKJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TISSUE CULTURE BAG is the device name listed in this FDA 510(k) record. The listed applicant is American Fluoroseal Corp.. It received FDA 510(k) clearance on 1987-03-30 under 510(k) number K870865. 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 BAG?

TISSUE CULTURE BAG is a medical device that received FDA 510(k) clearance on 1987-03-30. The listed applicant is American Fluoroseal Corp.. The 510(k) number is K870865.

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

TISSUE CULTURE BAG received FDA 510(k) clearance on 1987-03-30, under 510(k) number K870865.

Who is the listed applicant for TISSUE CULTURE BAG?

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

What is the FDA product code for TISSUE CULTURE BAG?

The FDA product code for TISSUE CULTURE BAG 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Fluoroseal Corp. 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.

K933228KAPTON PEEL POUCH

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 PreanalyticK873889TISSUE CULTURE TUBESNunc, Inc.K873890TISSUE CULTURE FLASKSNunc, 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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