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FDA 510(k)

TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)

K-Number: K920314 · 1992-04-17

ApplicantSyntex Corp.
Decision Date1992-04-17
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Corp.. It received FDA 510(k) clearance on 1992-04-17 under 510(k) number K920314. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)?

TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1992-04-17. The listed applicant is Syntex Corp.. The 510(k) number is K920314.

When did TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) receive FDA 510(k) clearance?

TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) received FDA 510(k) clearance on 1992-04-17, under 510(k) number K920314.

Who is the listed applicant for TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)?

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

What is the FDA product code for TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)?

The FDA product code for TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) is DIS.

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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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