The following data is part of a premarket notification filed by Western Laboratories Corp. with the FDA for Heparinometer.
| Device ID | K834024 |
| 510k Number | K834024 |
| Device Name: | HEPARINOMETER |
| Classification | Assay, Heparin |
| Applicant | WESTERN LABORATORIES CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-22 |
| Decision Date | 1984-06-11 |