510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850907Substantially Equivalent

Ck 1-3, Ld 1-5 Isoenzyme Control Human Levels 1/2/

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

K850907 is the FDA 510(k) clearance record for CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/, a class I device, cleared for Cala Diagnostics on under FDA product code JJT (Enzyme Controls (Assayed And Unassayed)). FDA records list 12 510(k) clearances for Cala Diagnostics, from to . As of , FDA records show no recalls naming K850907.

Clearance record

Decision date
Received
(112 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
Cala Diagnostics P.O. Box 6714, Los Osos CA
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