The following data is part of a premarket notification filed by Accriva Diagnostics, Inc. with the FDA for Gem Hemochron 100 System, Gem Hemochron 100 Activated Clotting Time Plus Test (act+), Gem Hemochron 100 Low Range Activated Clotting Time Test (act-lr), Directcheck Act+ Whole Blood Control, Level 1 And Level 2, Directcheck Act-lr Whole Blood Control.
| Device ID | K202101 |
| 510k Number | K202101 |
| Device Name: | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), DirectCHECK ACT+ Whole Blood Control, Level 1 And Level 2, DirectCHECK ACT-LR Whole Blood Control |
| 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 |
| Subsequent Product Code | GGN |
| Subsequent Product Code | JBP |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-29 |
| Decision Date | 2021-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234515006 | K202101 | 000 |
| 00711234170376 | K202101 | 000 |
| 00711234170369 | K202101 | 000 |
| 00711234170352 | K202101 | 000 |
| 00711234170345 | K202101 | 000 |
| 00711234103411 | K202101 | 000 |
| 00711234103404 | K202101 | 000 |
| 10711234540121 | K202101 | 000 |
| 10711234515044 | K202101 | 000 |