The following data is part of a premarket notification filed by Intensive Technology, Inc. with the FDA for Hemochron(r) Heparin Response Test.
| Device ID | K904003 |
| 510k Number | K904003 |
| Device Name: | HEMOCHRON(R) HEPARIN RESPONSE TEST |
| Classification | Assay, Heparin |
| Applicant | INTENSIVE TECHNOLOGY, INC. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Les Heimann |
| Correspondent | Les Heimann INTENSIVE TECHNOLOGY, INC. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1990-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234202036 | K904003 | 000 |
| 10711234102176 | K904003 | 000 |