510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K810592Substantially Equivalent

Nuclear Antigens

Alpha Antigens, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810592 is the FDA 510(k) clearance record for NUCLEAR ANTIGENS, a class II device, cleared for Alpha Antigens, Inc. on under FDA product code LLL (Extractable Antinuclear Antibody, Antigen And Control). FDA records list one 510(k) clearance for Alpha Antigens, Inc. As of , FDA records show no recalls naming K810592.

Clearance record

Decision date
Received
(232 days to decision)
Product code
LLL Extractable Antinuclear Antibody, Antigen And Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Alpha Antigens, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LLL

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