510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813339Substantially Equivalent

Direct Fa Conjugate for Legionella Sp

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

K813339 is the FDA 510(k) clearance record for DIRECT FA CONJUGATE FOR LEGIONELLA SP, a class II device, cleared for Springwood Microbiologicals on under FDA product code LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent). FDA records list 2 510(k) clearances for Springwood Microbiologicals, from to . As of , FDA records show no recalls naming K813339.

Clearance record

Decision date
Received
(24 days to decision)
Product code
LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Regulation
21 CFR 866.3300
Device class
Class II
Review panel
Microbiology
Applicant
Springwood Microbiologicals 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LHL

Trailing 12 months

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

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