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ABL 77 PH, Blood Gas and Electrolyte Analysis System

by Sendx Medical, Inc.

510(k) K994346

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK994346 Date1 Feb 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1173-2007 FDA Unclassified (pre-2012) initiated 19 Jun 2007

    Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CHL
Device Class
Class II
Regulation
21 CFR Part 862.1120
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ABL 77 PH, Blood Gas and Electrolyte Analysis System is an automated diagnostic system for measuring blood gases, electrolytes, and hematocrit. It performs electrochemical and conductometric analysis on arterial or venous whole blood samples to quantify pH, pO2, pCO2, Na+, K+, Cl-, Ca++, and hematocrit.

The device is used in clinical laboratories, near-patient, or point-of-care settings by healthcare professionals. It is supplied as a reusable system requiring periodic calibration and maintenance, with no indication of sterility or single-use designation in the provided data. Storage conditions and MRI safety are not specified in the device data. Authorisations include FDA 510(k) clearance under K994346, with product code CHL and regulation number 862.1120.

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