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FDA 510(k)

MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6

K-Number: K010878 · 2001-04-18

ApplicantDiagnostic Products Corp.
Decision Date2001-04-18
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 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 2001-04-18 under 510(k) number K010878. The device is classified under product code LGC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6?

MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 is a medical device that received FDA 510(k) clearance on 2001-04-18. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K010878.

When did MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 receive FDA 510(k) clearance?

MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 received FDA 510(k) clearance on 2001-04-18, under 510(k) number K010878.

Who is the listed applicant for MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6?

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 MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6?

The FDA product code for MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 is LGC.

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Other records listing Diagnostic Products Corp. as applicant

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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: LGC)

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.

K033059HERPES GROUP IGGTrinity Biotech, Inc.K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMDiamedix Corp.K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GMrl DiagnosticsK992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K983886POCKIT HSV 2 RAPID TESTDiagnology , Ltd.K984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTMeridian Diagnostics, 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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