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FDA 510(k)

CVM

K-Number: K914619 · 1991-11-22

ApplicantCiba Corning Diagnostics Corp.
Decision Date1991-11-22
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CVM is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Corning Diagnostics Corp.. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K914619. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVM?

CVM is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K914619.

When did CVM receive FDA 510(k) clearance?

CVM received FDA 510(k) clearance on 1991-11-22, under 510(k) number K914619.

Who is the listed applicant for CVM?

The FDA 510(k) record lists Ciba Corning Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CVM?

The FDA product code for CVM is JJY.

Other records listing Ciba Corning Diagnostics Corp. 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.

K962559ACS CORTISOL IMMUNOASSAYK963251CIBA CORNING ACS;180 DPD ASSAYK961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4K961657CIBA CORNING 400 SYSTEMK962021CIBA CORNING 348 SYSTEMK962126ACS CKMB II IMMUNOASSAY

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Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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