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FDA 510(k)

FIAX EB VCA-M TEST KIT

K-Number: K894932 · 1989-10-16

ApplicantWhittaker Bioproducts, Inc.
Decision Date1989-10-16
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAX EB VCA-M TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1989-10-16 under 510(k) number K894932. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX EB VCA-M TEST KIT?

FIAX EB VCA-M TEST KIT is a medical device that received FDA 510(k) clearance on 1989-10-16. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K894932.

When did FIAX EB VCA-M TEST KIT receive FDA 510(k) clearance?

FIAX EB VCA-M TEST KIT received FDA 510(k) clearance on 1989-10-16, under 510(k) number K894932.

Who is the listed applicant for FIAX EB VCA-M TEST KIT?

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

What is the FDA product code for FIAX EB VCA-M TEST KIT?

The FDA product code for FIAX EB VCA-M TEST KIT is LSE.

Other records listing Whittaker Bioproducts, 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.

K911356LEGIONELLA STAT IGG/IGM TEST KITK9132123M IGE SINGLE POINT FAST TESTK904652LYME STAT M TEST KITK904893FIAX LYME M TEST KITK911473EBNA STAT TEST KITK905468PYLORI-G FIAX TEST KIT

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Related Devices (Code: LSE)

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.

K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, 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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