510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884342Substantially Equivalent

Novapath Specimen Collection Kit

Bio-Rad, Hercules CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884342 is the FDA 510(k) clearance record for NOVAPATH SPECIMEN COLLECTION KIT, a class I device, cleared for Bio-Rad on under FDA product code LIO (Device, Specimen Collection). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K884342.

Clearance record

Decision date
Received
(20 days to decision)
Product code
LIO Device, Specimen Collection
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Bio-Rad 4000 Alfred Nobel Dr., Hercules CA
Third party review
No

Clearances, product code LIO

Trailing 12 months

FDA records hold no clearances under product code LIO in the trailing twelve months.

FDA records show no clearances under product code LIO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260