510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101434Substantially Equivalent

Audit Microcv Procalcitonin Linearity

Aalto Scientific Ltd., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101434 is the FDA 510(k) clearance record for AUDIT MICROCV PROCALCITONIN LINEARITY, a class I device, cleared for Aalto Scientific, Ltd. on under FDA product code MJX (Kit, Serological, Positive Control). FDA records list 35 510(k) clearances for Aalto Scientific, Ltd., from to . As of , FDA records show no recalls naming K101434.

Clearance record

Decision date
Received
(62 days to decision)
Product code
MJX Kit, Serological, Positive Control
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Aalto Scientific, Ltd. 1959 Kellogg Ave., Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MJX

Trailing 12 months

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

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