The following data is part of a premarket notification filed by Haemoscope Corp. with the FDA for Rapidteg Teg-act Test.
| Device ID | K062604 |
| 510k Number | K062604 |
| Device Name: | RAPIDTEG TEG-ACT TEST |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | HAEMOSCOPE CORP. 6231 W. HOWARD ST. Niles, IL 60714 |
| Contact | Eli Cohen |
| Correspondent | Eli Cohen HAEMOSCOPE CORP. 6231 W. HOWARD ST. Niles, IL 60714 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-01 |
| Decision Date | 2007-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20812747018088 | K062604 | 000 |