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 | K993678 |
| 510k Number | K993678 |
| 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 | 1999-11-01 |
| Decision Date | 2000-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747018412 | K993678 | 000 |
| 30812747018184 | K993678 | 000 |
| 20812747018132 | K993678 | 000 |
| 20812747018033 | K993678 | 000 |
| 20812747018026 | K993678 | 000 |
| 20812747018019 | K993678 | 000 |
| 20812747018002 | K993678 | 000 |
| 10812747018159 | K993678 | 000 |