The following data is part of a premarket notification filed by Ilex Corp. with the FDA for Ionized Calcium And Blood Ph Testcards.
| Device ID | K860639 |
| 510k Number | K860639 |
| Device Name: | IONIZED CALCIUM AND BLOOD PH TESTCARDS |
| Classification | Electrode, Ion Specific, Calcium |
| Applicant | ILEX CORP. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | W. A Morton |
| Correspondent | W. A Morton ILEX CORP. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | JFP |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-20 |
| Decision Date | 1986-04-21 |