510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K984234Substantially Equivalent

Quanta Lite Lyme Igm Elisa

Inova Diagnostics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984234 is the FDA 510(k) clearance record for QUANTA LITE LYME IGM ELISA, a class II device, cleared for Inova Diagnostics, Inc. on under FDA product code LSR (Reagent, Borrelia Serological Reagent). FDA records list 138 510(k) clearances for Inova Diagnostics, Inc., from to . As of , FDA records show no recalls naming K984234.

Clearance record

Decision date
Received
(141 days to decision)
Product code
LSR Reagent, Borrelia Serological Reagent
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Inova Diagnostics, Inc. 10180 Scripps Ranch Blvd., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code LSR

Trailing 12 months
1 clearance under product code LSR in the twelve months to November 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LSR, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260