FDA 510(k)

VERO CELLS

K-Number: K834124 · 1984-03-22

ApplicantBartels Immunodiagnostic Supplies, Inc.

Decision Date1984-03-22

Product CodeKIR

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

VERO CELLS is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1984-03-22 under 510(k) number K834124. 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 CELLS?

VERO CELLS is a medical device that received FDA 510(k) clearance on 1984-03-22. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K834124.

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

VERO CELLS received FDA 510(k) clearance on 1984-03-22, under 510(k) number K834124.

Who is the listed applicant for VERO CELLS?

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

What is the FDA product code for VERO CELLS?

The FDA product code for VERO CELLS is KIR.

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Other records listing Bartels Immunodiagnostic Supplies, Inc. as applicant

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Related Devices (Code: KIR)

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.