510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924248Substantially Equivalent

Accutex Sle Latex Test

J.S. Medical Assoc., Natick MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924248 is the FDA 510(k) clearance record for ACCUTEX SLE LATEX TEST, a class II device, cleared for J.S. Medical Assoc. on under FDA product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls). FDA records list 18 510(k) clearances for J.S. Medical Assoc., from to . As of , FDA records show no recalls naming K924248.

Clearance record

Decision date
Received
(70 days to decision)
Product code
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
J.S. Medical Assoc. 19 Strathmore Rd., Natick MA
510(k) summary
Statement
Third party review
No

Clearances, product code LJM

Trailing 12 months

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

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