CHLORIDE REAGENT— 510(k) K852169

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K852169 for CHLORIDE REAGENT, Substantially Equivalent on 1985-08-21. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CHJ
Device class: Class 2
Regulation: 21 CFR 862.1170
Advisory panel: Clinical Chemistry
Date received: 1985-05-20
Decision date: 1985-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHJ

K010670 — PICCOLO CHLORIDE TEST SYSTEM2001-04-26
K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER1995-02-22
K943006 — CHLORIDE QVET1994-12-07
K934136 — OLYMPUS CHLORIDE REAGENT, MODIFICATION1993-11-05
K932528 — OLYMPUS CHLORID REAGENT, MODIFIED1993-09-17

More clearances from Pointe Scientific, Inc.,

K070757 — MICROPROTEIN REAGENT SET2007-12-04
K062118 — POINTE 3602007-07-13
K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT2007-04-30
K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR2007-04-13
K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.