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FDA 510(k)

LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE

K-Number: K951440 · 1996-05-22

ApplicantViromed Laboratories, Inc.
Decision Date1996-05-22
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE 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 1996-05-22 under 510(k) number K951440. 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 LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE?

LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE is a medical device that received FDA 510(k) clearance on 1996-05-22. The listed applicant is Viromed Laboratories, Inc.. The 510(k) number is K951440.

When did LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE receive FDA 510(k) clearance?

LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE received FDA 510(k) clearance on 1996-05-22, under 510(k) number K951440.

Who is the listed applicant for LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE?

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 LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE?

The FDA product code for LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE is KIR.

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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.

K951461NCI-H292 CELL CULTUREK871613BUFFALO GREEN MONKEY KIDNEY CELLSK862555HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)K861373HUMAN LUNG CARCINOMA CELLS (A549)K853695RESPIRATORY SYNCYTIAL VIRUS ID REAGENTK852395MINK LUNG

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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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