510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884649Substantially Equivalent

Total Iron Binding Capacity Test

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

K884649 is the FDA 510(k) clearance record for TOTAL IRON BINDING CAPACITY TEST, a class I device, cleared for Sclavo, Inc. on under FDA product code JQE (Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity). FDA records list 82 510(k) clearances for Sclavo, Inc., from to . As of , FDA records show no recalls naming K884649.

Clearance record

Decision date
Received
(37 days to decision)
Product code
JQE Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Regulation
21 CFR 862.1415
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sclavo, Inc. 5 Mansard Ct., Wayne NJ
Third party review
No

Clearances, product code JQE

Trailing 12 months

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

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