The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-eu, Amax Destiny Coagulation Analyzer-refurbished.
| Device ID | K021162 |
| 510k Number | K021162 |
| Device Name: | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | William R Gilbert Ii |
| Correspondent | William R Gilbert Ii 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 | 2002-04-11 |
| Decision Date | 2002-08-30 |
| Summary: | summary |