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FDA 510(k)

ECLIPSE ICA GLUCOSE

K-Number: K905144 · 1991-01-04

ApplicantBiotope, Inc.
Decision Date1991-01-04
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ECLIPSE ICA GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Biotope, Inc.. It received FDA 510(k) clearance on 1991-01-04 under 510(k) number K905144. 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 ECLIPSE ICA GLUCOSE?

ECLIPSE ICA GLUCOSE is a medical device that received FDA 510(k) clearance on 1991-01-04. The listed applicant is Biotope, Inc.. The 510(k) number is K905144.

When did ECLIPSE ICA GLUCOSE receive FDA 510(k) clearance?

ECLIPSE ICA GLUCOSE received FDA 510(k) clearance on 1991-01-04, under 510(k) number K905144.

Who is the listed applicant for ECLIPSE ICA GLUCOSE?

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

What is the FDA product code for ECLIPSE ICA GLUCOSE?

The FDA product code for ECLIPSE ICA GLUCOSE is CFR.

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Other records listing Biotope, 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.

K905145ECLIPSE ICA CHOLESTEROLK910302ECLIPSE ICA ANALYZERK910256ECLIPSE ICA TSHK905601ECLIPSE ICA TRIGLYCERIDESK905719ECLIPSE ICA DIGOXINK905602ECLIPSE ICA BUN

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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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