510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K943291Substantially Equivalent

Anti Ds-DNA

Sigma Diagnostics, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943291 is the FDA 510(k) clearance record for ANTI DS-DNA, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code LLL (Extractable Antinuclear Antibody, Antigen And Control). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K943291.

Clearance record

Decision date
Received
(147 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
Sigma Diagnostics, Inc. 545 S. Ewing Ave., St. Louis MO
510(k) summary
Statement
Third party review
No

Clearances, product code LLL

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