510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993715Substantially Equivalent

Qualitrol Cardiac Marker Control, Levels, 1,2 and 3

Seracare Technology, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993715 is the FDA 510(k) clearance record for QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3, a class I device, cleared for Seracare Technology on under FDA product code JJT (Enzyme Controls (Assayed And Unassayed)). FDA records list 5 510(k) clearances for Seracare Technology, from to . As of , FDA records show no recalls naming K993715.

Clearance record

Decision date
Received
(13 days to decision)
Product code
JJT Enzyme Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Seracare Technology 2170 Woodward St., Austin TX
510(k) summary
Statement
Third party review
No

Clearances, product code JJT

Trailing 12 months

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

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