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FDA 510(k)

IMMULITE THYROGLOBULIN MODEL LKTY

K-Number: K982466 · 1999-03-12

ApplicantDiagnostic Products Corp.
Decision Date1999-03-12
Product CodeMSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE THYROGLOBULIN MODEL LKTY 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 1999-03-12 under 510(k) number K982466. The device is classified under product code MSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE THYROGLOBULIN MODEL LKTY?

IMMULITE THYROGLOBULIN MODEL LKTY is a medical device that received FDA 510(k) clearance on 1999-03-12. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K982466.

When did IMMULITE THYROGLOBULIN MODEL LKTY receive FDA 510(k) clearance?

IMMULITE THYROGLOBULIN MODEL LKTY received FDA 510(k) clearance on 1999-03-12, under 510(k) number K982466.

Who is the listed applicant for IMMULITE THYROGLOBULIN MODEL LKTY?

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 THYROGLOBULIN MODEL LKTY?

The FDA product code for IMMULITE THYROGLOBULIN MODEL LKTY is MSW.

Related Clinical Trials

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.

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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: MSW)

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.

K242981Atellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc.K240927Access ThyroglobulinBeckman Coulter, Inc.K241423Access ThyroglobulinBeckman Coulter, Inc.K221890Elecsys Tg IIRoche DiagnosticsK220972Access ThyroglobulinBeckman Coulter, Inc.K031269ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, 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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