The following data is part of a premarket notification filed by Haemoscope Corp. with the FDA for Thrombelastograph Coagulation Analyzer Teg-5000 Series.
| Device ID | K002177 |
| 510k Number | K002177 |
| Device Name: | THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | HAEMOSCOPE CORP. 7855 GROSS POINT RD. SUITE G4 Skokie, IL 60077 |
| Contact | Eli Cohen |
| Correspondent | Eli Cohen HAEMOSCOPE CORP. 7855 GROSS POINT RD. SUITE G4 Skokie, IL 60077 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-19 |
| Decision Date | 2000-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10812747018043 | K002177 | 000 |