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FDA 510(k)

STRATUS(R) AUTOMATED SAMPLE HANDLER

K-Number: K911712 · 1991-05-15

ApplicantBaxter Healthcare Corp
Decision Date1991-05-15
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS(R) AUTOMATED SAMPLE HANDLER 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 1991-05-15 under 510(k) number K911712. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS(R) AUTOMATED SAMPLE HANDLER?

STRATUS(R) AUTOMATED SAMPLE HANDLER is a medical device that received FDA 510(k) clearance on 1991-05-15. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K911712.

When did STRATUS(R) AUTOMATED SAMPLE HANDLER receive FDA 510(k) clearance?

STRATUS(R) AUTOMATED SAMPLE HANDLER received FDA 510(k) clearance on 1991-05-15, under 510(k) number K911712.

Who is the listed applicant for STRATUS(R) AUTOMATED SAMPLE HANDLER?

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) AUTOMATED SAMPLE HANDLER?

The FDA product code for STRATUS(R) AUTOMATED SAMPLE HANDLER is JQW.

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Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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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