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FDA 510(k)

WI-38

K-Number: K841806 · 1984-06-07

ApplicantViromed Laboratories, Inc.
Decision Date1984-06-07
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

WI-38 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 1984-06-07 under 510(k) number K841806. 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?

WI-38 is a medical device that received FDA 510(k) clearance on 1984-06-07. The listed applicant is Viromed Laboratories, Inc.. The 510(k) number is K841806.

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

WI-38 received FDA 510(k) clearance on 1984-06-07, under 510(k) number K841806.

Who is the listed applicant for WI-38?

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 WI-38?

The FDA product code for WI-38 is KIR.

Other records listing Viromed Laboratories, Inc. 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.

K951440LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTUREK951461NCI-H292 CELL CULTUREK871613BUFFALO GREEN MONKEY KIDNEY CELLSK862555HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)K861373HUMAN LUNG CARCINOMA CELLS (A549)K853695RESPIRATORY SYNCYTIAL VIRUS ID REAGENT

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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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