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FDA 510(k)

COULTER GLUCOSE REAGENT

K-Number: K897160 · 1990-03-09

ApplicantCoulter Electronics, Inc.
Decision Date1990-03-09
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER GLUCOSE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1990-03-09 under 510(k) number K897160. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER GLUCOSE REAGENT?

COULTER GLUCOSE REAGENT is a medical device that received FDA 510(k) clearance on 1990-03-09. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K897160.

When did COULTER GLUCOSE REAGENT receive FDA 510(k) clearance?

COULTER GLUCOSE REAGENT received FDA 510(k) clearance on 1990-03-09, under 510(k) number K897160.

Who is the listed applicant for COULTER GLUCOSE REAGENT?

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

What is the FDA product code for COULTER GLUCOSE REAGENT?

The FDA product code for COULTER GLUCOSE REAGENT is CFR.

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Other records listing Coulter Electronics, 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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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