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FDA 510(k)

ACCU-CHEK HQ SYSTEM

K-Number: K983047 · 1999-02-05

ApplicantBoehringer Mannheim Corp.
Decision Date1999-02-05
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK HQ SYSTEM 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 1999-02-05 under 510(k) number K983047. The device is classified under product code LFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHEK HQ SYSTEM?

ACCU-CHEK HQ SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-05. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K983047.

When did ACCU-CHEK HQ SYSTEM receive FDA 510(k) clearance?

ACCU-CHEK HQ SYSTEM received FDA 510(k) clearance on 1999-02-05, under 510(k) number K983047.

Who is the listed applicant for ACCU-CHEK HQ SYSTEM?

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 ACCU-CHEK HQ SYSTEM?

The FDA product code for ACCU-CHEK HQ SYSTEM is LFR.

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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 ASSAYK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TESTK983503ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347

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Related Devices (Code: LFR)

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.

K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical CorporationK121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical CorporationK113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology 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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