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FDA 510(k)

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)

K-Number: K891385 · 1989-04-18

ApplicantVitek Systems, Inc.
Decision Date1989-04-18
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1989-04-18 under 510(k) number K891385. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)?

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) is a medical device that received FDA 510(k) clearance on 1989-04-18. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K891385.

When did VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) receive FDA 510(k) clearance?

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) received FDA 510(k) clearance on 1989-04-18, under 510(k) number K891385.

Who is the listed applicant for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)?

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

What is the FDA product code for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)?

The FDA product code for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) is DEW.

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Other records listing Vitek Systems, 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.

K920661VIDAS CMV IGG ASSAYK921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

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Related Devices (Code: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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