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FDA 510(k)

BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL

K-Number: K963213 · 1996-10-23

ApplicantBoehringer Mannheim Corp.
Decision Date1996-10-23
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1996-10-23 under 510(k) number K963213. 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 BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL?

BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1996-10-23. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K963213.

When did BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL receive FDA 510(k) clearance?

BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL received FDA 510(k) clearance on 1996-10-23, under 510(k) number K963213.

Who is the listed applicant for BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL?

The FDA product code for BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL is LBS.

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Other records listing Boehringer Mannheim 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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