510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970580Substantially Equivalent

Sasi-Dc1ts

Substance Abuse Specialties, Inc., Research Triangle Park NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970580 is the FDA 510(k) clearance record for SASI-DC1TS, a class I device, cleared for Substance Abuse Specialties, Inc. on under FDA product code KDW (Container, Specimen Mailer And Storage, Temperature Controlled, Sterile). FDA records list one 510(k) clearance for Substance Abuse Specialties, Inc. As of , FDA records show no recalls naming K970580.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KDW Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
Regulation
21 CFR 864.3250
Device class
Class I
Review panel
Pathology
Applicant
Substance Abuse Specialties, Inc. P.O.Box 14587, Research Triangle Park NC
510(k) summary
Statement
Third party review
No

Clearances, product code KDW

Trailing 12 months

FDA records hold no clearances under product code KDW in the trailing twelve months.

FDA records show no clearances under product code KDW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KDW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260