The following data is part of a premarket notification filed by Sirchie Finger Print Laboratories, Inc. with the FDA for Sex Crimes/sex Assault Vict/suspect Evid Coll Kits.
Device ID | K915814 |
510k Number | K915814 |
Device Name: | SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | SIRCHIE FINGER PRINT LABORATORIES, INC. P.O. BOX 30576 Raleigh, NC 27622 |
Contact | James W Gocke |
Correspondent | James W Gocke SIRCHIE FINGER PRINT LABORATORIES, INC. P.O. BOX 30576 Raleigh, NC 27622 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-30 |
Decision Date | 1992-03-27 |