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FDA 510(k)

HDLC PRECIPITATING REAGENT

K-Number: K982539 · 1998-09-15

ApplicantAc Biochemicals, Inc.
Decision Date1998-09-15
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDLC PRECIPITATING REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Ac Biochemicals, Inc.. It received FDA 510(k) clearance on 1998-09-15 under 510(k) number K982539. 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 HDLC PRECIPITATING REAGENT?

HDLC PRECIPITATING REAGENT is a medical device that received FDA 510(k) clearance on 1998-09-15. The listed applicant is Ac Biochemicals, Inc.. The 510(k) number is K982539.

When did HDLC PRECIPITATING REAGENT receive FDA 510(k) clearance?

HDLC PRECIPITATING REAGENT received FDA 510(k) clearance on 1998-09-15, under 510(k) number K982539.

Who is the listed applicant for HDLC PRECIPITATING REAGENT?

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

What is the FDA product code for HDLC PRECIPITATING REAGENT?

The FDA product code for HDLC PRECIPITATING REAGENT is LBS.

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Other records listing Ac Biochemicals, 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.

K980012CREATINE KINASE REAGENTK980013AMYLASE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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