FDA 510(k)

HUMAN NEWBORN FORESKIN CELL CULTURE

K-Number: K943887 · 1994-11-28

Decision Date1994-11-28

Product CodeKIR

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HUMAN NEWBORN FORESKIN CELL CULTURE 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 K943887. 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 HUMAN NEWBORN FORESKIN CELL CULTURE?

HUMAN NEWBORN FORESKIN CELL CULTURE is a medical device that received FDA 510(k) clearance on 1994-11-28. The listed applicant is Neogenex. The 510(k) number is K943887.

When did HUMAN NEWBORN FORESKIN CELL CULTURE receive FDA 510(k) clearance?

HUMAN NEWBORN FORESKIN CELL CULTURE received FDA 510(k) clearance on 1994-11-28, under 510(k) number K943887.

Who is the listed applicant for HUMAN NEWBORN FORESKIN CELL CULTURE?

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 HUMAN NEWBORN FORESKIN CELL CULTURE?

The FDA product code for HUMAN NEWBORN FORESKIN CELL CULTURE is KIR.

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Other records listing Neogenex as applicant

K965047MINK LUNG CELL CULTURE K960909H292 CELL CULTURE K943886BGM CELL CULTURE K943888MDCK CELL CULTURE K943884PRIMARY MONKEY KIDNEY CELL CULTURE K943890WI38 CELL CULTURE

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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.