510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971335Substantially Equivalent

Quanta Lite Cmv Igg Elisa

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

K971335 is the FDA 510(k) clearance record for QUANTA LITE CMV IGG ELISA, a class II device, cleared for Inova Diagnostics, Inc. on under FDA product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus). FDA records list 138 510(k) clearances for Inova Diagnostics, Inc., from to . As of , FDA records show no recalls naming K971335.

Clearance record

Decision date
Received
(235 days to decision)
Product code
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Inova Diagnostics, Inc. 10451 Roselle St., San Diego CA
510(k) summary
Statement
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260