510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881608Substantially Equivalent

Merifluor(tm) Pneumocystis

Meridian Diagnostics, Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881608 is the FDA 510(k) clearance record for MERIFLUOR(TM) PNEUMOCYSTIS, a class II device, cleared for Meridian Diagnostics, Inc. on under FDA product code LYF (Pneumocystis Carinii). FDA records list 92 510(k) clearances for Meridian Diagnostics, Inc., from to . As of , FDA records show no recalls naming K881608.

Clearance record

Decision date
Received
(114 days to decision)
Product code
LYF Pneumocystis Carinii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Meridian Diagnostics, Inc. 3471 River Hills Dr., Cincinnati OH
Third party review
No

Clearances, product code LYF

Trailing 12 months

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

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