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FDA 510(k)

INCSTAR RUBELLA IGG ELISA ASSAY

K-Number: K960367 · 1996-10-24

ApplicantIncstar Corp.
Decision Date1996-10-24
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INCSTAR RUBELLA IGG ELISA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1996-10-24 under 510(k) number K960367. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCSTAR RUBELLA IGG ELISA ASSAY?

INCSTAR RUBELLA IGG ELISA ASSAY is a medical device that received FDA 510(k) clearance on 1996-10-24. The listed applicant is Incstar Corp.. The 510(k) number is K960367.

When did INCSTAR RUBELLA IGG ELISA ASSAY receive FDA 510(k) clearance?

INCSTAR RUBELLA IGG ELISA ASSAY received FDA 510(k) clearance on 1996-10-24, under 510(k) number K960367.

Who is the listed applicant for INCSTAR RUBELLA IGG ELISA ASSAY?

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

What is the FDA product code for INCSTAR RUBELLA IGG ELISA ASSAY?

The FDA product code for INCSTAR RUBELLA IGG ELISA ASSAY is LFX.

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Other records listing Incstar 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.

K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530K953567INCSTAR 25-HYDROXYVITMIN D 1251 RIA

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Related Devices (Code: LFX)

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.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche Diagnostics

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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