510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010670Substantially Equivalent

Piccolo Chloride Test System

Abaxis Inc, Union City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010670 is the FDA 510(k) clearance record for PICCOLO CHLORIDE TEST SYSTEM, a class II device, cleared for Abaxis, Inc. on under FDA product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride). FDA records list 20 510(k) clearances for Abaxis, Inc., from to . As of , FDA records show no recalls naming K010670.

Clearance record

Decision date
Received
(51 days to decision)
Product code
CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Regulation
21 CFR 862.1170
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abaxis, Inc. 3240 Whipple Rd., Union City CA
510(k) summary
Summary
Third party review
No

Clearances, product code CHJ

Trailing 12 months

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

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