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FDA 510(k)

GLUCOSE TEST ITEM NUMBER 97375/94

K-Number: K951750 · 1995-09-06

ApplicantEmd Chemicals, Inc.
Decision Date1995-09-06
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE TEST ITEM NUMBER 97375/94 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 1995-09-06 under 510(k) number K951750. 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 GLUCOSE TEST ITEM NUMBER 97375/94?

GLUCOSE TEST ITEM NUMBER 97375/94 is a medical device that received FDA 510(k) clearance on 1995-09-06. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K951750.

When did GLUCOSE TEST ITEM NUMBER 97375/94 receive FDA 510(k) clearance?

GLUCOSE TEST ITEM NUMBER 97375/94 received FDA 510(k) clearance on 1995-09-06, under 510(k) number K951750.

Who is the listed applicant for GLUCOSE TEST ITEM NUMBER 97375/94?

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 GLUCOSE TEST ITEM NUMBER 97375/94?

The FDA product code for GLUCOSE TEST ITEM NUMBER 97375/94 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)K950234TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2

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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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