Submission Details
| 510(k) Number | K060768 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 2006 |
| Decision Date | April 21, 2006 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
Apr 2006
Decision
30d
Days
Class 1
Risk
About This 510(k) Submission
K060768 is an FDA 510(k) clearance for the PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS, a Nitroprusside, Ketones (urinary, Non-quant.) (Class I — General Controls, product code JIN), submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on April 21, 2006, 30 days after receiving the submission on March 22, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1435.
Device Classification
| Product Code | JIN — Nitroprusside, Ketones (urinary, Non-quant.) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1435 |
Manufacturer
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