FDA 510(k)

IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6

K-Number: K012075 · 2002-01-10

Decision Date2002-01-10

Product CodeLGD

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 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 2002-01-10 under 510(k) number K012075. 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 IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6?

IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 is a medical device that received FDA 510(k) clearance on 2002-01-10. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K012075.

When did IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 receive FDA 510(k) clearance?

IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 received FDA 510(k) clearance on 2002-01-10, under 510(k) number K012075.

Who is the listed applicant for IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6?

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 IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6?

The FDA product code for IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 is LGD.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Diagnostic Products Corp. as applicant

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCIN K034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I K033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER K032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE K023152IMMULITE 2000 ALLERGEN-SPECIFIC IGE K023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 devices →

Related Devices (Code: LGD)

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott Laboratories K210596ARCHITECT Toxo IgGAbbott Laboratories K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics K132234LIAISON(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.