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FDA 510(k)

RUBELISA (RUBESTAT)

K-Number: K950227 · 1995-08-15

ApplicantBio-Whittaker, Inc., A Cambrex Co.
Decision Date1995-08-15
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELISA (RUBESTAT) is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Whittaker, Inc., A Cambrex Co.. It received FDA 510(k) clearance on 1995-08-15 under 510(k) number K950227. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBELISA (RUBESTAT)?

RUBELISA (RUBESTAT) is a medical device that received FDA 510(k) clearance on 1995-08-15. The listed applicant is Bio-Whittaker, Inc., A Cambrex Co.. The 510(k) number is K950227.

When did RUBELISA (RUBESTAT) receive FDA 510(k) clearance?

RUBELISA (RUBESTAT) received FDA 510(k) clearance on 1995-08-15, under 510(k) number K950227.

Who is the listed applicant for RUBELISA (RUBESTAT)?

The FDA 510(k) record lists Bio-Whittaker, Inc., A Cambrex Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBELISA (RUBESTAT)?

The FDA product code for RUBELISA (RUBESTAT) is LFX.

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Other records listing Bio-Whittaker, Inc., A Cambrex Co. 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.

K971508RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTUREK944867TOXOSTAT

Related Devices (Code: LFX)

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.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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