The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Blood Gas Kit (non-sterile) Reorder No. 0560.
| Device ID | K930986 |
| 510k Number | K930986 |
| Device Name: | BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 |
| Classification | Arterial Blood Sampling Kit |
| Applicant | CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Contact | Felix B Santos |
| Correspondent | Felix B Santos CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-25 |
| Decision Date | 1993-07-14 |