The following data is part of a premarket notification filed by Epocal, Inc. with the FDA for Blood Collection Tube Samples For Use With Point Of Care Blood Analyzer.
| Device ID | K092849 |
| 510k Number | K092849 |
| Device Name: | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER |
| Classification | Electrode, Ion Specific, Potassium |
| 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 | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CHL |
| Subsequent Product Code | GIO |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JPI |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-16 |
| Decision Date | 2010-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00809708041137 | K092849 | 000 |