The following data is part of a premarket notification filed by Haemoscope Corp. with the FDA for Thrombelastograph (teg) Platelet Mapping Assay.
| Device ID | K041502 |
| 510k Number | K041502 |
| Device Name: | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY |
| Classification | System, Automated Platelet Aggregation |
| Applicant | HAEMOSCOPE CORP. 5693 WEST HOWARD Niles, IL 60714 |
| Contact | Eli Cohen |
| Correspondent | Eli Cohen HAEMOSCOPE CORP. 5693 WEST HOWARD Niles, IL 60714 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-07 |
| Decision Date | 2004-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20812747018125 | K041502 | 000 |
| 20812747018118 | K041502 | 000 |
| 20812747018101 | K041502 | 000 |