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FDA 510(k)

RD CULTURE CELL

K-Number: K943891 · 1994-11-28

ApplicantNeogenex
Decision Date1994-11-28
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RD 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 1994-11-28 under 510(k) number K943891. 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 RD CULTURE CELL?

RD CULTURE CELL is a medical device that received FDA 510(k) clearance on 1994-11-28. The listed applicant is Neogenex. The 510(k) number is K943891.

When did RD CULTURE CELL receive FDA 510(k) clearance?

RD CULTURE CELL received FDA 510(k) clearance on 1994-11-28, under 510(k) number K943891.

Who is the listed applicant for RD 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 RD CULTURE CELL?

The FDA product code for RD 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.

K965047MINK LUNG CELL CULTUREK960909H292 CELL CULTUREK943887HUMAN NEWBORN FORESKIN CELL CULTUREK943888MDCK CELL CULTUREK943884PRIMARY MONKEY KIDNEY CELL CULTUREK943890WI38 CELL CULTURE

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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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