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FDA 510(k)

HEP-2 CULTURE CELL

K-Number: K933927 · 1994-03-31

ApplicantNeogenex
Decision Date1994-03-31
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEP-2 CULTURE CELL is the device name listed in this FDA 510(k) record. The listed applicant is Neogenex. It received FDA 510(k) clearance on 1994-03-31 under 510(k) number K933927. 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 CULTURE CELL?

HEP-2 CULTURE CELL is a medical device that received FDA 510(k) clearance on 1994-03-31. The listed applicant is Neogenex. The 510(k) number is K933927.

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

HEP-2 CULTURE CELL received FDA 510(k) clearance on 1994-03-31, under 510(k) number K933927.

Who is the listed applicant for HEP-2 CULTURE CELL?

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

What is the FDA product code for HEP-2 CULTURE CELL?

The FDA product code for HEP-2 CULTURE CELL is KIR.

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Other records listing Neogenex 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.

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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

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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