510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K874375Substantially Equivalent

Abbott Testpack Rotavirus Positive Control

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874375 is the FDA 510(k) clearance record for ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL, a class I device, cleared for Abbott Laboratories on under FDA product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K874375.

Clearance record

Decision date
Received
(45 days to decision)
Product code
LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Regulation
21 CFR 866.3405
Device class
Class I
Review panel
Microbiology
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
Third party review
No

Clearances, product code LIQ

Trailing 12 months

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

FDA records show no clearances under product code LIQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIQ, 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