510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992252Substantially Equivalent

Light Diagnostics Pneumocystis Carinii Dfa, Model 31965

Chemicon Intl., Inc., Temecula CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K992252 is the FDA 510(k) clearance record for LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965, a class II device, cleared for Chemicon Intl., Inc. on under FDA product code LYF (Pneumocystis Carinii). FDA records list 8 510(k) clearances for Chemicon Intl., Inc., from to . As of , FDA records show no recalls naming K992252.

Clearance record

Decision date
Received
(35 days to decision)
Product code
LYF Pneumocystis Carinii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Chemicon Intl., Inc. 28835 Single Oak Dr., Temecula CA
510(k) summary
Statement
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