510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051144Substantially Equivalent

Acetylcholine Receptor Ab (Arab)rra

Ibl-Hamburg GmbH, East Stroudsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051144 is the FDA 510(k) clearance record for ACETYLCHOLINE RECEPTOR AB (ARAB)RRA, a class II device, cleared for Ibl-Hamburg GmbH 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 2 510(k) clearances for Ibl-Hamburg GmbH, from to . As of , FDA records show no recalls naming K051144.

Clearance record

Decision date
Received
(198 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
Ibl-Hamburg GmbH 150 Cherry Ln. Rd., East Stroudsburg PA
510(k) summary
Summary PDF
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