510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841064Substantially Equivalent

Alkaline Phosphotase Reagent Set

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

K841064 is the FDA 510(k) clearance record for ALKALINE PHOSPHOTASE REAGENT SET, a class II device, cleared for Medical Specialties, Inc. on under FDA product code CIO (Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes). FDA records list 40 510(k) clearances for Medical Specialties, Inc., from to . As of , FDA records show no recalls naming K841064.

Clearance record

Decision date
Received
(50 days to decision)
Product code
CIO Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Regulation
21 CFR 862.1050
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Medical Specialties, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CIO

Trailing 12 months

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

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