Hemochron Signature Elite
System, Multipurpose For In Vitro Coagulation Studies
Accriva Diagnostics, Inc.
The following data is part of a premarket notification filed by Accriva Diagnostics, Inc. with the FDA for Hemochron Signature Elite.
Pre-market Notification Details
| Device ID | K193041 |
| 510k Number | K193041 |
| Device Name: | Hemochron Signature Elite |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | Accriva Diagnostics, Inc. 6260 Sequence Drive San Diego, CA 92121 |
| Contact | Brian James |
| Correspondent | Brian James Accriva Diagnostics, Inc. 6260 Sequence Drive San Diego, CA 92121 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-31 |
| Decision Date | 2019-11-22 |
Trademark Results [Hemochron Signature Elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOCHRON SIGNATURE ELITE 78415261 3036770 Live/Registered |
ACCRIVA DIAGNOSTICS, INC. 2004-05-07 |
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