HEMOGLOBIN— 510(k) K851432

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K851432 for HEMOGLOBIN, Substantially Equivalent on 1985-07-12. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1985-04-10
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHG

K221508 — AnemoCheck Home2023-09-29
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K001462 — CARESIDE HEMOGLOBIN2000-08-21

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.