The following data is part of a premarket notification filed by Haemachem, Inc. with the FDA for Heptest-a Quantitative Heparin In Plasma Assay.
| Device ID | K853239 |
| 510k Number | K853239 |
| Device Name: | HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY |
| Classification | Assay, Heparin |
| Applicant | HAEMACHEM, INC. 2335 SOUTH HANLEY RD. St. Louis, MO 63144 |
| Contact | Thye Yin |
| Correspondent | Thye Yin HAEMACHEM, INC. 2335 SOUTH HANLEY RD. St. Louis, MO 63144 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-01 |
| Decision Date | 1985-11-05 |