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FDA 510(k)

WI-38 CELLS

K-Number: K833359 · 1983-11-03

ApplicantBiocon, Inc.
Decision Date1983-11-03
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

WI-38 CELLS is the device name listed in this FDA 510(k) record. The listed applicant is Biocon, Inc.. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K833359. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WI-38 CELLS?

WI-38 CELLS is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Biocon, Inc.. The 510(k) number is K833359.

When did WI-38 CELLS receive FDA 510(k) clearance?

WI-38 CELLS received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833359.

Who is the listed applicant for WI-38 CELLS?

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

What is the FDA product code for WI-38 CELLS?

The FDA product code for WI-38 CELLS is KIR.

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 Biocon, 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.

K833360HEP-2 CELLSK833358MRC-5 CELLS

Related Devices (Code: KIR)

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.

K973212FRESH CELLS WI-38Diagnostic Hybrids, Inc.K973210FRESH CELLS NCI H292Diagnostic Hybrids, Inc.K973209FRESH CELLS VERODiagnostic Hybrids, Inc.K973211FRESH CELLS MV1LUDiagnostic Hybrids, Inc.K973213FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.K973214FRESH CELLS HFFDiagnostic Hybrids, 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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