510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000556Substantially Equivalent

Atac Pak Glucose Reagent and Atac Calibrator Kits

Elan Diagnostics, Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000556 is the FDA 510(k) clearance record for ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS, a class II device, cleared for Elan Diagnostics on under FDA product code CFR (Hexokinase, Glucose). FDA records list 13 510(k) clearances for Elan Diagnostics, from to . As of , FDA records show no recalls naming K000556.

Clearance record

Decision date
Received
(89 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Elan Diagnostics 231 N. Puente St., Brea CA
510(k) summary
Summary
Third party review
No

Clearances, product code CFR

Trailing 12 months
1 clearance under product code CFR in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260