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FDA 510(k)

ULTRACHEM GLUC-DH, ITEM NO. 65048

K-Number: K811202 · 1981-05-27

ApplicantHarleco
Decision Date1981-05-27
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM GLUC-DH, ITEM NO. 65048 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-05-27 under 510(k) number K811202. 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 ULTRACHEM GLUC-DH, ITEM NO. 65048?

ULTRACHEM GLUC-DH, ITEM NO. 65048 is a medical device that received FDA 510(k) clearance on 1981-05-27. The listed applicant is Harleco. The 510(k) number is K811202.

When did ULTRACHEM GLUC-DH, ITEM NO. 65048 receive FDA 510(k) clearance?

ULTRACHEM GLUC-DH, ITEM NO. 65048 received FDA 510(k) clearance on 1981-05-27, under 510(k) number K811202.

Who is the listed applicant for ULTRACHEM GLUC-DH, ITEM NO. 65048?

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

What is the FDA product code for ULTRACHEM GLUC-DH, ITEM NO. 65048?

The FDA product code for ULTRACHEM GLUC-DH, ITEM NO. 65048 is LFR.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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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