510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091468Substantially Equivalent

IVD Technologies Achrab Test Kit

Ivd Technologies, East Stroudsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K091468 is the FDA 510(k) clearance record for IVD TECHNOLOGIES ACHRAB TEST KIT, a class II device, cleared for Ivd Technologies on under FDA product code NST (Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking). FDA's definition for product code NST reads: "THE DEVICE IS AN IMMUNOASSAY INDICATED AS AN AID IN THE DIAGNOSIS OF MYASTHENIA GRAVIS, AN AUTOIMMUNE DISEASE CHARACTERIZED BY EXERCISE-INDUCED MUSCLE WEAKNESS TEMPORARILY RELIEVED BY CESSATION OF EXERCISE. AUTOANTIBODY, WHEN PRESENT IN...". FDA records list one 510(k) clearance for Ivd Technologies. As of , FDA records show no recalls naming K091468.

Clearance record

Decision date
Received
(186 days to decision)
Product code
NST Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Ivd Technologies 150 Cherry Ln. Rd., East Stroudsburg PA
510(k) summary
Statement
Third party review
No

Clearances, product code NST

Trailing 12 months

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

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