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FDA 510(k)

HDL-C EIKEN

K-Number: K813192 · 1981-11-27

ApplicantSyn-Kit, Inc.
Decision Date1981-11-27
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL-C EIKEN is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1981-11-27 under 510(k) number K813192. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDL-C EIKEN?

HDL-C EIKEN is a medical device that received FDA 510(k) clearance on 1981-11-27. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K813192.

When did HDL-C EIKEN receive FDA 510(k) clearance?

HDL-C EIKEN received FDA 510(k) clearance on 1981-11-27, under 510(k) number K813192.

Who is the listed applicant for HDL-C EIKEN?

The FDA 510(k) record lists Syn-Kit, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDL-C EIKEN?

The FDA product code for HDL-C EIKEN is LBS.

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Other records listing Syn-Kit, Inc. 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843758UROPAPER EIKEN GK

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Related Devices (Code: LBS)

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.

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation

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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