510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163538Substantially Equivalent

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

Inova Diagnostics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163538 is the FDA 510(k) clearance record for QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls, a class II device, cleared for Inova Diagnostics, Inc. on under FDA product code NBS (Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)). FDA records list 138 510(k) clearances for Inova Diagnostics, Inc., from to . As of , FDA records show no recalls naming K163538.

Clearance record

Decision date
Received
(264 days to decision)
Product code
NBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Inova Diagnostics, Inc. 9900 Old Grove Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBS

Trailing 12 months

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

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