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FDA 510(k)

DATA-TOPE TRI-RAC RADIOASSAY CONTROL

K-Number: K790264 · 1979-03-21

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1979-03-21
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA-TOPE TRI-RAC RADIOASSAY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-03-21 under 510(k) number K790264. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATA-TOPE TRI-RAC RADIOASSAY CONTROL?

DATA-TOPE TRI-RAC RADIOASSAY CONTROL is a medical device that received FDA 510(k) clearance on 1979-03-21. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K790264.

When did DATA-TOPE TRI-RAC RADIOASSAY CONTROL receive FDA 510(k) clearance?

DATA-TOPE TRI-RAC RADIOASSAY CONTROL received FDA 510(k) clearance on 1979-03-21, under 510(k) number K790264.

Who is the listed applicant for DATA-TOPE TRI-RAC RADIOASSAY CONTROL?

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

What is the FDA product code for DATA-TOPE TRI-RAC RADIOASSAY CONTROL?

The FDA product code for DATA-TOPE TRI-RAC RADIOASSAY CONTROL is JJY.

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Related Devices (Code: JJY)

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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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