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FDA 510(k)

ULTRACHEM GLUC-DH, #65048

K-Number: K821469 · 1982-06-02

ApplicantEmd Chemicals, Inc.
Decision Date1982-06-02
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM GLUC-DH, #65048 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1982-06-02 under 510(k) number K821469. 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, #65048?

ULTRACHEM GLUC-DH, #65048 is a medical device that received FDA 510(k) clearance on 1982-06-02. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K821469.

When did ULTRACHEM GLUC-DH, #65048 receive FDA 510(k) clearance?

ULTRACHEM GLUC-DH, #65048 received FDA 510(k) clearance on 1982-06-02, under 510(k) number K821469.

Who is the listed applicant for ULTRACHEM GLUC-DH, #65048?

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

What is the FDA product code for ULTRACHEM GLUC-DH, #65048?

The FDA product code for ULTRACHEM GLUC-DH, #65048 is LFR.

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Other records listing Emd Chemicals, 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.

K031367DUOPATH VEROTOXINS GLISA TESTK990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK981926ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)K951750GLUCOSE TEST ITEM NUMBER 97375/94

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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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