510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951206Substantially Equivalent

Varelisa Parietal Cell Antibodies

Elias U.S.A., Inc., Osceola WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951206 is the FDA 510(k) clearance record for VARELISA PARIETAL CELL ANTIBODIES, a class II device, cleared for Elias U.S.A., Inc. on under FDA product code MLE (Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control). FDA records list 54 510(k) clearances for Elias U.S.A., Inc., from to . As of , FDA records show no recalls naming K951206.

Clearance record

Decision date
Received
(31 days to decision)
Product code
MLE Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Regulation
21 CFR 866.5110
Device class
Class II
Review panel
Immunology
Applicant
Elias U.S.A., Inc. 373 280th St., Osceola WI
510(k) summary
Statement
Third party review
No

Clearances, product code MLE

Trailing 12 months

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

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