The following data is part of a premarket notification filed by J.j. Skinner, Inc. with the FDA for Jj Skinner Carekits(tm) Blood Collection Kit.
| Device ID | K925468 |
| 510k Number | K925468 |
| Device Name: | JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT |
| Classification | Tray, Blood Collection |
| Applicant | J.J. SKINNER, INC. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook J.J. SKINNER, INC. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Product Code | GJE |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-29 |
| Decision Date | 1994-04-11 |