510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K864456Substantially Equivalent

Cyclosporin a (Whole Blood) Control - Levels 1,2,3

Cala Diagnostics, Los Osos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864456 is the FDA 510(k) clearance record for CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3, a class I device, cleared for Cala Diagnostics on under FDA product code LAS (Drug Specific Control Materials). FDA records list 12 510(k) clearances for Cala Diagnostics, from to . As of , FDA records show no recalls naming K864456.

Clearance record

Decision date
Received
(174 days to decision)
Product code
LAS Drug Specific Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Cala Diagnostics P.O. Box 6714, Los Osos CA
Third party review
No

Clearances, product code LAS

Trailing 12 months

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

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