The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Prestige Blood Glucose Monitoring System,meter,test Strips & Prestige High And Low Glucose Control.
| Device ID | K960855 |
| 510k Number | K960855 |
| Device Name: | PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL |
| Classification | Glucose Oxidase, Glucose |
| Applicant | HOME DIAGNOSTICS, INC. 2600 N.W. 55TH COURT SUITE #239 Ft Lauderdale, FL 33309 |
| Contact | Vik Bajnath |
| Correspondent | Vik Bajnath HOME DIAGNOSTICS, INC. 2600 N.W. 55TH COURT SUITE #239 Ft Lauderdale, FL 33309 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-01 |
| Decision Date | 1996-11-07 |