510(k) K970580
K970580 is an FDA 510(k) premarket notification submitted by Substance Abuse Specialties, Inc. for the device "SASI-DC1TS". The FDA issued a decision of Substantially Equivalent on April 17, 1997. The device falls under product code KDW (Container, Specimen Mailer And Storage, Temperature Controlled, Sterile), a Class I device regulated under 21 CFR 864.3250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 1997
- Date Received
- February 14, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
- Device Class
- Class I
- Regulation Number
- 864.3250
- Review Panel
- PA
- Submission Type