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FDA 510(k)

CENTOCOR CA 15-3 RIA MODEL NO. 800-033

K-Number: K963803 · 1997-05-23

ApplicantCentocor, Inc.
Decision Date1997-05-23
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CENTOCOR CA 15-3 RIA MODEL NO. 800-033 is the device name listed in this FDA 510(k) record. The listed applicant is Centocor, Inc.. It received FDA 510(k) clearance on 1997-05-23 under 510(k) number K963803. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTOCOR CA 15-3 RIA MODEL NO. 800-033?

CENTOCOR CA 15-3 RIA MODEL NO. 800-033 is a medical device that received FDA 510(k) clearance on 1997-05-23. The listed applicant is Centocor, Inc.. The 510(k) number is K963803.

When did CENTOCOR CA 15-3 RIA MODEL NO. 800-033 receive FDA 510(k) clearance?

CENTOCOR CA 15-3 RIA MODEL NO. 800-033 received FDA 510(k) clearance on 1997-05-23, under 510(k) number K963803.

Who is the listed applicant for CENTOCOR CA 15-3 RIA MODEL NO. 800-033?

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

What is the FDA product code for CENTOCOR CA 15-3 RIA MODEL NO. 800-033?

The FDA product code for CENTOCOR CA 15-3 RIA MODEL NO. 800-033 is MOI.

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Other records listing Centocor, Inc. as applicant

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Related Devices (Code: MOI)

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.

K240403Access BR MonitorBeckman Coulter, Inc.K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.K181492Elecsys CA 15-3 IIRoche 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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