The following data is part of a premarket notification filed by Epocal, Inc. with the FDA for Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-fill Capillary Tube.
| Device ID | K093297 |
| 510k Number | K093297 |
| Device Name: | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | EPOCAL, INC. 2060 WALKLEY RD. Ottawa, Ontario, CA K1g-3p5 |
| Contact | Roy Layer |
| Correspondent | Roy Layer EPOCAL, INC. 2060 WALKLEY RD. Ottawa, Ontario, CA K1g-3p5 |
| Product Code | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-21 |
| Decision Date | 2010-06-09 |
| Summary: | summary |