510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912826Substantially Equivalent

Whole Blood Alcohol Control, Level 1 & 2

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

K912826 is the FDA 510(k) clearance record for WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2, a class I device, cleared for Cala Diagnostics on under FDA product code DKC (Alcohol Control Materials). FDA records list 12 510(k) clearances for Cala Diagnostics, from to . As of , FDA records show no recalls naming K912826.

Clearance record

Decision date
Received
(30 days to decision)
Product code
DKC Alcohol 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
510(k) summary
Statement
Third party review
No

Clearances, product code DKC

Trailing 12 months

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

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