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FDA 510(k)

IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06

K-Number: K991096 · 1999-05-13

ApplicantDiagnostic Products Corp.
Decision Date1999-05-13
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 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 1999-05-13 under 510(k) number K991096. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06?

IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 is a medical device that received FDA 510(k) clearance on 1999-05-13. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K991096.

When did IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 receive FDA 510(k) clearance?

IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 received FDA 510(k) clearance on 1999-05-13, under 510(k) number K991096.

Who is the listed applicant for IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06?

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 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06?

The FDA product code for IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 is JZO.

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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

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Related Devices (Code: JZO)

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.

K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K222610Elecsys Anti-TgRoche DiagnosticsK193313Elecsys Anti-TSHRRoche DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB

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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