The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Customed Blood Extraction Kit.
| Device ID | K962596 |
| 510k Number | K962596 |
| Device Name: | CUSTOMED BLOOD EXTRACTION KIT |
| Classification | Tray, Blood Collection |
| Applicant | CUSTOMED, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula CUSTOMED, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | GJE |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-02 |
| Decision Date | 1996-09-27 |
| Summary: | summary |