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FDA 510(k)

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C

K-Number: K812556 · 1981-11-02

ApplicantAmerican Dade
Decision Date1981-11-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812556. 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 DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C?

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is American Dade. The 510(k) number is K812556.

When did DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C receive FDA 510(k) clearance?

DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812556.

Who is the listed applicant for DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C?

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

What is the FDA product code for DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C?

The FDA product code for DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C is JJY.

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Related Devices (Code: JJY)

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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