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FDA 510(k)

WI-38 GENCELLS

K-Number: K851561 · 1985-05-10

ApplicantGenus Diagnostics
Decision Date1985-05-10
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

WI-38 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 1985-05-10 under 510(k) number K851561. 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 WI-38 GENCELLS?

WI-38 GENCELLS is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Genus Diagnostics. The 510(k) number is K851561.

When did WI-38 GENCELLS receive FDA 510(k) clearance?

WI-38 GENCELLS received FDA 510(k) clearance on 1985-05-10, under 510(k) number K851561.

Who is the listed applicant for WI-38 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 WI-38 GENCELLS?

The FDA product code for WI-38 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 GENCELLSK851927VERO GENCELLSK851928HEK 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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