The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Accu-chek Compact System, Accu-chek Compact Test Strips, Accu-chek Compact Compact Controls.
| Device ID | K004010 |
| 510k Number | K004010 |
| Device Name: | ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Luann Ochs |
| Correspondent | Luann Ochs ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-04-26 |