The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Cs-400 Coagulation Analyzer System (a1208).
| Device ID | K972260 |
| 510k Number | K972260 |
| Device Name: | CS-400 COAGULATION ANALYZER SYSTEM (A1208) |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | William R Gilbert |
| Correspondent | William R Gilbert SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-17 |
| Decision Date | 1997-10-20 |
| Summary: | summary |