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FDA 510(k)

MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT

K-Number: K884249 · 1989-04-10

ApplicantDisease Detection International, Inc.
Decision Date1989-04-10
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Disease Detection International, Inc.. It received FDA 510(k) clearance on 1989-04-10 under 510(k) number K884249. 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 MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT?

MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT is a medical device that received FDA 510(k) clearance on 1989-04-10. The listed applicant is Disease Detection International, Inc.. The 510(k) number is K884249.

When did MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT receive FDA 510(k) clearance?

MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT received FDA 510(k) clearance on 1989-04-10, under 510(k) number K884249.

Who is the listed applicant for MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT?

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

What is the FDA product code for MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT?

The FDA product code for MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT is LGD.

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Other records listing Disease Detection International, Inc. as applicant

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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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