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FDA 510(k)

VERO GENCELLS

K-Number: K851927 · 1985-05-20

ApplicantGenus Diagnostics
Decision Date1985-05-20
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VERO GENCELLS is the device name listed in this FDA 510(k) record. The listed applicant is Genus Diagnostics. It received FDA 510(k) clearance on 1985-05-20 under 510(k) number K851927. 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 VERO GENCELLS?

VERO GENCELLS is a medical device that received FDA 510(k) clearance on 1985-05-20. The listed applicant is Genus Diagnostics. The 510(k) number is K851927.

When did VERO GENCELLS receive FDA 510(k) clearance?

VERO GENCELLS received FDA 510(k) clearance on 1985-05-20, under 510(k) number K851927.

Who is the listed applicant for VERO GENCELLS?

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

What is the FDA product code for VERO GENCELLS?

The FDA product code for VERO GENCELLS is KIR.

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Other records listing Genus 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.

K854974HSV IDRK852204MCCOY GENCELLSK852205RMK GENCELLS CULTURE SYSTEMK852206HEP-2 GENCELLSK851928HEK GENCELLSK851561WI-38 GENCELLS

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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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