Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5

K-Number: K981297 · 1998-09-18

ApplicantDiagnostic Products Corp.
Decision Date1998-09-18
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 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 1998-09-18 under 510(k) number K981297. The device is classified under product code LTK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5?

IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 is a medical device that received FDA 510(k) clearance on 1998-09-18. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K981297.

When did IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 receive FDA 510(k) clearance?

IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 received FDA 510(k) clearance on 1998-09-18, under 510(k) number K981297.

Who is the listed applicant for IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5?

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 OM-MA, MODELS LKOPZ, LKOP1, LKOP5?

The FDA product code for IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 is LTK.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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: LTK)

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.

K240479Access OV MonitorBeckman Coulter, Inc.K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd.K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical DiagnosticsK200199ADVIA Centaur CA 125IISiemens Healthcare Diagnostics, Inc.K100321DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604Siemens Healthcare DiagnosticsK080469VIDAS CA 15-3 ASSAYbioMerieux, 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.

↑