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FDA 510(k)

IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2

K-Number: K983263 · 1998-12-07

ApplicantDiagnostic Products Corp.
Decision Date1998-12-07
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 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 1998-12-07 under 510(k) number K983263. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2?

IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 is a medical device that received FDA 510(k) clearance on 1998-12-07. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K983263.

When did IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 receive FDA 510(k) clearance?

IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 received FDA 510(k) clearance on 1998-12-07, under 510(k) number K983263.

Who is the listed applicant for IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2?

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 AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2?

The FDA product code for IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 is LOJ.

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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: LOJ)

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.

K220176Elecsys AFPRoche DiagnosticsK213626VITROS AFPOrtho Clinical DiagnosticsK090236DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454Siemens Healthcare DiagnosticsK081709OLYMPUS AFP - ALPHA-FETOPROTEINOlympus Life Science Research Europa GmbH (Europa)K080017VIDAS AFP ASSAYbioMerieux, Inc.K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600Dade Behring, 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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