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FDA 510(k)

HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2

K-Number: K934243 · 1994-01-03

ApplicantAdvanced Clinical Diagnostics
Decision Date1994-01-03
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Clinical Diagnostics. It received FDA 510(k) clearance on 1994-01-03 under 510(k) number K934243. 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 EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2?

HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 is a medical device that received FDA 510(k) clearance on 1994-01-03. The listed applicant is Advanced Clinical Diagnostics. The 510(k) number is K934243.

When did HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 receive FDA 510(k) clearance?

HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 received FDA 510(k) clearance on 1994-01-03, under 510(k) number K934243.

Who is the listed applicant for HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2?

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

What is the FDA product code for HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2?

The FDA product code for HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 is KIR.

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Other records listing Advanced Clinical Diagnostics as applicant

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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.

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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.

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