SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS
Device Facts
| Record ID | K915814 |
|---|---|
| Device Name | SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS |
| Applicant | Sirchie Finger Print Laboratories, Inc. |
| Product Code | JKA · Clinical Chemistry |
| Decision Date | Mar 27, 1992 |
| Decision | SESK |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
