510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831343Substantially Equivalent

Cmv Rq Bio-Enzabead Kit

Litton Bionetics, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831343 is the FDA 510(k) clearance record for CMV RQ BIO-ENZABEAD KIT, a class II device, cleared for Litton Bionetics on under FDA product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus). FDA records list 15 510(k) clearances for Litton Bionetics, from to . As of , FDA records show no recalls naming K831343.

Clearance record

Decision date
Received
(105 days to decision)
Product code
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Litton Bionetics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LFZ

Trailing 12 months

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

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