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FDA 510(k)

HELA-229/HELA CELLS

K-Number: K934973 · 1994-01-28

ApplicantAdvanced Clinical Diagnostics
Decision Date1994-01-28
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HELA-229/HELA CELLS 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 1994-01-28 under 510(k) number K934973. 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 HELA-229/HELA CELLS?

HELA-229/HELA CELLS is a medical device that received FDA 510(k) clearance on 1994-01-28. The listed applicant is Advanced Clinical Diagnostics. The 510(k) number is K934973.

When did HELA-229/HELA CELLS receive FDA 510(k) clearance?

HELA-229/HELA CELLS received FDA 510(k) clearance on 1994-01-28, under 510(k) number K934973.

Who is the listed applicant for HELA-229/HELA CELLS?

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 HELA-229/HELA CELLS?

The FDA product code for HELA-229/HELA CELLS is KIR.

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Other records listing Advanced Clinical Diagnostics 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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