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FDA 510(k)

IMMULITE TOXOPLASMA GONDII IGG

K-Number: K950671 · 1996-02-23

ApplicantDiagnostic Products Corp.
Decision Date1996-02-23
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMULITE TOXOPLASMA GONDII IGG is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1996-02-23 under 510(k) number K950671. 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 IMMULITE TOXOPLASMA GONDII IGG?

IMMULITE TOXOPLASMA GONDII IGG is a medical device that received FDA 510(k) clearance on 1996-02-23. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K950671.

When did IMMULITE TOXOPLASMA GONDII IGG receive FDA 510(k) clearance?

IMMULITE TOXOPLASMA GONDII IGG received FDA 510(k) clearance on 1996-02-23, under 510(k) number K950671.

Who is the listed applicant for IMMULITE TOXOPLASMA GONDII IGG?

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

What is the FDA product code for IMMULITE TOXOPLASMA GONDII IGG?

The FDA product code for IMMULITE TOXOPLASMA GONDII IGG is LGD.

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Other records listing Diagnostic Products 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 devices →

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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