The following data is part of a premarket notification filed by Izon Business Products, Inc. with the FDA for Multiple (izon Blood & Urine Collection Kit).
| Device ID | K950221 |
| 510k Number | K950221 |
| Device Name: | MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) |
| Classification | Kit, Screening, Urine |
| Applicant | IZON BUSINESS PRODUCTS, INC. 520 WEST NYACK RD. West Nyack, NY 10994 |
| Contact | Jack Wertz |
| Correspondent | Jack Wertz IZON BUSINESS PRODUCTS, INC. 520 WEST NYACK RD. West Nyack, NY 10994 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-19 |
| Decision Date | 1995-03-21 |