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FDA 510(k)

ECLIPSE ICA BUN

K-Number: K905602 · 1991-01-16

ApplicantBiotope, Inc.
Decision Date1991-01-16
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ECLIPSE ICA BUN is the device name listed in this FDA 510(k) record. The listed applicant is Biotope, Inc.. It received FDA 510(k) clearance on 1991-01-16 under 510(k) number K905602. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECLIPSE ICA BUN?

ECLIPSE ICA BUN is a medical device that received FDA 510(k) clearance on 1991-01-16. The listed applicant is Biotope, Inc.. The 510(k) number is K905602.

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

ECLIPSE ICA BUN received FDA 510(k) clearance on 1991-01-16, under 510(k) number K905602.

Who is the listed applicant for ECLIPSE ICA BUN?

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 BUN?

The FDA product code for ECLIPSE ICA BUN is CDQ.

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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 DIGOXINK905144ECLIPSE ICA GLUCOSE

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Related Devices (Code: CDQ)

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.

K203771Urea Nitrogen2Abbott Ireland Diagnostics DivisionK110675EASYRA UREA NITROGEN AND CREATININE REAGENTSMedica Corp.K073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OYK070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba AbxK060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMTeco DiagnosticsK041051RAICHEM BUN RATE REAGENT (LIQUID)Hemagen Diagnostics, Inc.

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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