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FDA 510(k)

ABUSCREEN FP BUFFER REAGENT

K-Number: K890883 · 1989-03-15

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1989-03-15
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN FP BUFFER REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1989-03-15 under 510(k) number K890883. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN FP BUFFER REAGENT?

ABUSCREEN FP BUFFER REAGENT is a medical device that received FDA 510(k) clearance on 1989-03-15. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K890883.

When did ABUSCREEN FP BUFFER REAGENT receive FDA 510(k) clearance?

ABUSCREEN FP BUFFER REAGENT received FDA 510(k) clearance on 1989-03-15, under 510(k) number K890883.

Who is the listed applicant for ABUSCREEN FP BUFFER REAGENT?

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

What is the FDA product code for ABUSCREEN FP BUFFER REAGENT?

The FDA product code for ABUSCREEN FP BUFFER REAGENT is DIO.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: DIO)

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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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