510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981375Substantially Equivalent

Ace T Uptake Reagent Tu Calibrators

Schiapparelli Biosystems, Inc., Fairfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981375 is the FDA 510(k) clearance record for ACE T UPTAKE REAGENT TU CALIBRATORS, a class II device, cleared for Schiapparelli Biosystems, Inc. on under FDA product code KHQ (Radioassay, Triiodothyronine Uptake). FDA records list 24 510(k) clearances for Schiapparelli Biosystems, Inc., from to . As of , FDA records show no recalls naming K981375.

Clearance record

Decision date
Received
(55 days to decision)
Product code
KHQ Radioassay, Triiodothyronine Uptake
Regulation
21 CFR 862.1715
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Schiapparelli Biosystems, Inc. 368 Passaic Ave., Fairfield NJ
510(k) summary
Summary
Third party review
No

Clearances, product code KHQ

Trailing 12 months

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

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