510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092911Substantially Equivalent

Smart Hba1c Assay Kit, Model Dz168b-Poc, Smart Hba1c Assay Control Kit, Model Dz168b-Con, Smart Hbac1c Analyzer

Diazyme Laboratories, Inc., Poway CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092911 is the FDA 510(k) clearance record for SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER, a class I device, cleared for Diazyme Laboratories on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list 52 510(k) clearances for Diazyme Laboratories, from to . As of , FDA records show no recalls naming K092911.

Clearance record

Decision date
Received
(216 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diazyme Laboratories 12889 Gregg Ct., Poway CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

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