The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Diascan Control.
| Device ID | K853553 |
| 510k Number | K853553 |
| Device Name: | DIASCAN CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | HOME DIAGNOSTICS, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Jerry B Slaven |
| Correspondent | Jerry B Slaven HOME DIAGNOSTICS, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1985-09-16 |