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FDA 510(k)

RLP CHOLESTEROL IMMUNOSEPARATION ASSAY

K-Number: K991083 · 1999-08-20

ApplicantOtsuka Pharmaceutical Co., Ltd.
Decision Date1999-08-20
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RLP CHOLESTEROL IMMUNOSEPARATION ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Otsuka Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 1999-08-20 under 510(k) number K991083. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RLP CHOLESTEROL IMMUNOSEPARATION ASSAY?

RLP CHOLESTEROL IMMUNOSEPARATION ASSAY is a medical device that received FDA 510(k) clearance on 1999-08-20. The listed applicant is Otsuka Pharmaceutical Co., Ltd.. The 510(k) number is K991083.

When did RLP CHOLESTEROL IMMUNOSEPARATION ASSAY receive FDA 510(k) clearance?

RLP CHOLESTEROL IMMUNOSEPARATION ASSAY received FDA 510(k) clearance on 1999-08-20, under 510(k) number K991083.

Who is the listed applicant for RLP CHOLESTEROL IMMUNOSEPARATION ASSAY?

The FDA 510(k) record lists Otsuka Pharmaceutical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RLP CHOLESTEROL IMMUNOSEPARATION ASSAY?

The FDA product code for RLP CHOLESTEROL IMMUNOSEPARATION ASSAY is CHH.

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.

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Other records listing Otsuka Pharmaceutical Co., Ltd. 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.

K092817POC-AS10 AUTO SAMPLERK052716RAPIRUN H. PYLORI ANTIBODY DETECTION KITK041148POCONE INFRARED SPECTROPHOTOMETERK013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMK001032RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON 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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