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FDA 510(k)

IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5

K-Number: K994085 · 2000-01-28

ApplicantDiagnostic Products Corp.
Decision Date2000-01-28
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 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 2000-01-28 under 510(k) number K994085. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5?

IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 is a medical device that received FDA 510(k) clearance on 2000-01-28. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K994085.

When did IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 receive FDA 510(k) clearance?

IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 received FDA 510(k) clearance on 2000-01-28, under 510(k) number K994085.

Who is the listed applicant for IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5?

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 TURBO HCG, MODELS LSKCG1, LSKCG5?

The FDA product code for IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 is DHA.

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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: DHA)

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.

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical DiagnosticsK223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott LaboratoriesK230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott LaboratoriesK221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, 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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