FDA 510(k)

SASI-DC1TS

K-Number: K970580 · 1997-04-17

ApplicantSubstance Abuse Specialties, Inc.

Decision Date1997-04-17

Product CodeKDW

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

SASI-DC1TS is the device name listed in this FDA 510(k) record. The listed applicant is Substance Abuse Specialties, Inc.. It received FDA 510(k) clearance on 1997-04-17 under 510(k) number K970580. The device is classified under product code KDW. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SASI-DC1TS?

SASI-DC1TS is a medical device that received FDA 510(k) clearance on 1997-04-17. The listed applicant is Substance Abuse Specialties, Inc.. The 510(k) number is K970580.

When did SASI-DC1TS receive FDA 510(k) clearance?

SASI-DC1TS received FDA 510(k) clearance on 1997-04-17, under 510(k) number K970580.

Who is the listed applicant for SASI-DC1TS?

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

What is the FDA product code for SASI-DC1TS?

The FDA product code for SASI-DC1TS is KDW.

Related Devices (Code: KDW)

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.

K951122CAPITOL URINE DRUG SCREEN COLLECTION KITHarry A. Schlakman K931474DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITSGbf Medical Group K913967DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEMDoxtech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.