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FDA 510(k)

CYNOMOLGUS MONKEY KIDNEY CELLS SV5

K-Number: K831684 · 1983-07-06

ApplicantViromed Laboratories, Inc.
Decision Date1983-07-06
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CYNOMOLGUS MONKEY KIDNEY CELLS SV5 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 1983-07-06 under 510(k) number K831684. 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 CYNOMOLGUS MONKEY KIDNEY CELLS SV5?

CYNOMOLGUS MONKEY KIDNEY CELLS SV5 is a medical device that received FDA 510(k) clearance on 1983-07-06. The listed applicant is Viromed Laboratories, Inc.. The 510(k) number is K831684.

When did CYNOMOLGUS MONKEY KIDNEY CELLS SV5 receive FDA 510(k) clearance?

CYNOMOLGUS MONKEY KIDNEY CELLS SV5 received FDA 510(k) clearance on 1983-07-06, under 510(k) number K831684.

Who is the listed applicant for CYNOMOLGUS MONKEY KIDNEY CELLS SV5?

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 CYNOMOLGUS MONKEY KIDNEY CELLS SV5?

The FDA product code for CYNOMOLGUS MONKEY KIDNEY CELLS SV5 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.

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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