The following data is part of a premarket notification filed by Mid-atlantic Diagnostics, Inc. with the FDA for Custom Products Ivf Workstation Type Wkst-24*36, Wkst-24*48, Wkst-24*60, Wkst-24*72 And Wkst-24*72d Plus Accessories.
| Device ID | K030525 |
| 510k Number | K030525 |
| Device Name: | CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES |
| Classification | Accessory, Assisted Reproduction |
| Applicant | MID-ATLANTIC DIAGNOSTICS, INC. 438 NORTH ELMWOOD RD. Marlton, NJ 08053 |
| Contact | Susan J Bush |
| Correspondent | Susan J Bush MID-ATLANTIC DIAGNOSTICS, INC. 438 NORTH ELMWOOD RD. Marlton, NJ 08053 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-08-27 |