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FDA 510(k)

RAPITEX(R) RF NEW

K-Number: K903852 · 1990-08-30

ApplicantBehring Diagnostics, Inc.
Decision Date1990-08-30
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RAPITEX(R) RF NEW is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-08-30 under 510(k) number K903852. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPITEX(R) RF NEW?

RAPITEX(R) RF NEW is a medical device that received FDA 510(k) clearance on 1990-08-30. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K903852.

When did RAPITEX(R) RF NEW receive FDA 510(k) clearance?

RAPITEX(R) RF NEW received FDA 510(k) clearance on 1990-08-30, under 510(k) number K903852.

Who is the listed applicant for RAPITEX(R) RF NEW?

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

What is the FDA product code for RAPITEX(R) RF NEW?

The FDA product code for RAPITEX(R) RF NEW is DHR.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: DHR)

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.

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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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