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FDA 510(k)

HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)

K-Number: K862555 · 1986-07-10

ApplicantViromed Laboratories, Inc.
Decision Date1986-07-10
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) is the device name listed in this FDA 510(k) record. The listed applicant is Viromed Laboratories, Inc.. It received FDA 510(k) clearance on 1986-07-10 under 510(k) number K862555. 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 EPITHELOID CERVIX CARCINOMA CELLS (HELA)?

HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) is a medical device that received FDA 510(k) clearance on 1986-07-10. The listed applicant is Viromed Laboratories, Inc.. The 510(k) number is K862555.

When did HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) receive FDA 510(k) clearance?

HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) received FDA 510(k) clearance on 1986-07-10, under 510(k) number K862555.

Who is the listed applicant for HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)?

The FDA 510(k) record lists Viromed Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)?

The FDA product code for HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) is KIR.

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Other records listing Viromed Laboratories, Inc. 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.

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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