510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K863682Substantially Equivalent

Pathfinder(tm) Specimen Collection Kit

Kallestad Laboratories, Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863682 is the FDA 510(k) clearance record for PATHFINDER(TM) SPECIMEN COLLECTION KIT, a class I device, cleared for Kallestad Laboratories, Inc. on under FDA product code JSM (Culture Media, Non-Propagating Transport). FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from to . As of , FDA records show no recalls naming K863682.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JSM Culture Media, Non-Propagating Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Applicant
Kallestad Laboratories, Inc. 1000 Lake Hazeltine Dr., Chaska MN
Third party review
No

Clearances, product code JSM

Trailing 12 months
1 clearance under product code JSM in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JSM, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260