The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test Strips.
| Device ID | K060768 |
| 510k Number | K060768 |
| Device Name: | PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Maria E Trejo |
| Correspondent | Maria E Trejo ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-22 |
| Decision Date | 2006-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30093815707463 | K060768 | 000 |
| 30093815707456 | K060768 | 000 |