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FDA 510(k)

HEP-2 CELLS

K-Number: K833360 · 1983-11-03

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

Device Summary

HEP-2 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 K833360. 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 HEP-2 CELLS?

HEP-2 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 K833360.

When did HEP-2 CELLS receive FDA 510(k) clearance?

HEP-2 CELLS received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833360.

Who is the listed applicant for HEP-2 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 HEP-2 CELLS?

The FDA product code for HEP-2 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.

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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.

K833358MRC-5 CELLSK833359WI-38 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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