K001043 is an FDA 510(k) clearance for the KAWASUMI LABORATORY BLOOD DRAWING KIT. This device is classified as a Set, Transfer (blood/plasma) (Class II - Special Controls, product code KSB).
Submitted by Kawasumi Laboratories America, Inc. (Tampa, US). The FDA issued a Cleared decision on May 19, 2000, 49 days after receiving the submission on March 31, 2000.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9875.
| 510(k) Number | K001043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2000 |
| Decision Date | May 19, 2000 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KSB — Set, Transfer (blood/plasma) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9875 |