510(k) K970580
- Device
- Sasi-dc1ts
- Applicant
- SUBSTANCE ABUSE SPECIALTIES, INC.
- 510(k) number
- K970580
- Product code
- KDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-17
- Date received
- 1997-02-14
- Regulation
- 864.3250
- Classification name
- Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LIBBY HAMILTON
- Address
- P.O.Box 14587 Research Triangle Park NC US 27709 27709
FDA Registration Numbers#
- 3005572604
- 3014150341
- 3030708766
- 3030626857
- 3010194621
- 1219930
- 1055358
- 3013557562
- 2244900
- 3006210673
- 2647580
- 3007544634
- 3013188547
- 3017210488
- 1226230
- 3011945100
- 3006897996
- 3018094310
Source Documents#
510(k) summary PDF not indicated by FDA