510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K915814Unknown

Sex Crimes/sex Assault Vict/suspect Evid Coll Kits

Sirchie Finger Print Laboratories, Inc., Raleigh NC / Traditional, Unknown
FDA source (opens on fda.gov)

K915814 is the FDA 510(k) clearance record for SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS, a class II device, cleared for Sirchie Finger Print Laboratories, Inc. on under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection). FDA records list one 510(k) clearance for Sirchie Finger Print Laboratories, Inc. As of , FDA records show no recalls naming K915814.

Clearance record

Decision date
Received
(88 days to decision)
Product code
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sirchie Finger Print Laboratories, Inc. P.O. Box 30576, Raleigh NC
510(k) summary
Statement
Third party review
No

Clearances, product code JKA

Trailing 12 months
6 clearances under product code JKA in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code JKA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20263
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260