The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Syntegra.
| Device ID | K041182 |
| 510k Number | K041182 |
| Device Name: | SYNTEGRA |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Joy M Sacmar |
| Correspondent | Elizabeth Drew UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-05-06 |
| Decision Date | 2004-05-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SYNTEGRA 97315786 not registered Live/Pending |
Syntegra, Inc. 2022-03-16 |
![]() SYNTEGRA 97129779 not registered Live/Pending |
Syntegra Services, LLC 2021-11-17 |
![]() SYNTEGRA 86169026 not registered Dead/Abandoned |
NPS Pharmaceuticals, Inc. 2014-01-17 |
![]() SYNTEGRA 85094495 not registered Dead/Abandoned |
NPS Pharmaceuticals, Inc. 2010-07-28 |
![]() SYNTEGRA 79354598 not registered Live/Pending |
Concordia Capital Netherlands B.V. 2022-05-28 |
![]() SYNTEGRA 79234789 5790273 Live/Registered |
Semperit Technische Produkte Gesellschaft m.b.H. 2018-05-29 |
![]() SYNTEGRA 79032568 3360026 Dead/Cancelled |
Siemens Aktiengesellschaft 2006-08-01 |
![]() SYNTEGRA 78224889 not registered Dead/Abandoned |
NPS Pharmaceuticals, Inc. 2003-03-12 |
![]() SYNTEGRA 77082341 not registered Dead/Abandoned |
NPS Pharmaceuticals, Inc. 2007-01-12 |
![]() SYNTEGRA 75540966 2451431 Dead/Cancelled |
DOW CHEMICAL COMPANY, THE 1998-08-24 |
![]() SYNTEGRA 75382719 2464799 Dead/Cancelled |
British Telecommunications plc 1997-10-31 |
![]() SYNTEGRA 74450846 1959568 Dead/Cancelled |
British Telecommunications 1993-10-22 |