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FDA 510(k)

INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY

K-Number: K963289 · 1997-05-01

ApplicantIncstar Corp.
Decision Date1997-05-01
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INCSTAR TOXOPLASMA IGM CAPTURE 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 1997-05-01 under 510(k) number K963289. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY?

INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY is a medical device that received FDA 510(k) clearance on 1997-05-01. The listed applicant is Incstar Corp.. The 510(k) number is K963289.

When did INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY receive FDA 510(k) clearance?

INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY received FDA 510(k) clearance on 1997-05-01, under 510(k) number K963289.

Who is the listed applicant for INCSTAR TOXOPLASMA IGM CAPTURE 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 TOXOPLASMA IGM CAPTURE ELISA ASSAY?

The FDA product code for INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY is LGD.

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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.

K963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K960367INCSTAR RUBELLA IGG ELISA ASSAYK960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530K953567INCSTAR 25-HYDROXYVITMIN D 1251 RIA

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Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, 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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