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FDA 510(k)

TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)

K-Number: K990685 · 1999-03-26

ApplicantAb Biodisk
Decision Date1999-03-26
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1999-03-26 under 510(k) number K990685. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)?

TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) is a medical device that received FDA 510(k) clearance on 1999-03-26. The listed applicant is Ab Biodisk. The 510(k) number is K990685.

When did TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) receive FDA 510(k) clearance?

TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) received FDA 510(k) clearance on 1999-03-26, under 510(k) number K990685.

Who is the listed applicant for TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)?

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

What is the FDA product code for TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)?

The FDA product code for TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) is JWY.

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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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