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FDA 510(k)

STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES

K-Number: K890908 · 1989-03-24

ApplicantBaxter Healthcare Corp
Decision Date1989-03-24
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-03-24 under 510(k) number K890908. The device is classified under product code KHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES?

STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1989-03-24. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K890908.

When did STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES receive FDA 510(k) clearance?

STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES received FDA 510(k) clearance on 1989-03-24, under 510(k) number K890908.

Who is the listed applicant for STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES?

The FDA product code for STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES is KHO.

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Related Devices (Code: KHO)

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.

K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Radiometer Medical ApsK973547TRIAGE STATMETERBiosite IncorporatedK971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.K962919VITROS IMMUNODIAGNOSTIC SYSTEMJohnson & Johnson Clinical Diagnostics, Inc.K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)Biocircuits Corp.K950415FLUOROSCAN NEONATALIsolab, 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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