510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880049Substantially Equivalent

Cholinesterase - Butyrythiocholine Substrate

Sclavo, Inc., Wayne NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880049 is the FDA 510(k) clearance record for CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE, a class I device, cleared for Sclavo, Inc. on under FDA product code DIH (Colorimetry, Cholinesterase). FDA records list 82 510(k) clearances for Sclavo, Inc., from to . As of , FDA records show no recalls naming K880049.

Clearance record

Decision date
Received
(387 days to decision)
Product code
DIH Colorimetry, Cholinesterase
Regulation
21 CFR 862.3240
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Sclavo, Inc. 5 Mansard Ct., Wayne NJ
Third party review
No

Clearances, product code DIH

Trailing 12 months

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

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