510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K982217Substantially Equivalent

Ac/ad Linearity Verifiers

Sc Calibrators & Controls, LLC, Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982217 is the FDA 510(k) clearance record for AC/AD LINEARITY VERIFIERS, a class I device, cleared for Sc Calibrators & Controls, LLC on under FDA product code DIF (Drug Mixture Control Materials). FDA records list 3 510(k) clearances for Sc Calibrators & Controls, LLC, from to . As of , FDA records show no recalls naming K982217.

Clearance record

Decision date
Received
(8 days to decision)
Product code
DIF Drug Mixture Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Sc Calibrators & Controls, LLC 1701 Berkeley St., Santa Monica CA
510(k) summary
Summary
Third party review
Yes

Clearances, product code DIF

Trailing 12 months

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

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