HCP-7— 510(k) K790415

Substantially Equivalent

Bioscientific

FDA 510(k) clearance K790415 for HCP-7, Substantially Equivalent on 1979-04-04. Applicant: Bioscientific. Device class: 2.

Clearance details

Applicant: Bioscientific
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1979-02-26
Decision date: 1979-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPK

K160586 — XN-L CHECK2016-12-22
K160588 — XN CHECK BF2016-12-22
K160590 — XN CHECK2016-12-22
K160606 — BC-5D Hematology Control2016-09-01
K141957 — XN CHECK BF2014-12-05

More clearances from Bioscientific

K812447 — AMYLASE REAGENT KIT1981-09-09
K811251 — CITRATE BUFFER1981-05-21
K801265 — WHITE BLOOD CELL COUNT CONTROL LEVELS1980-07-14
K801267 — RED BLOOD CELL COUNT & HEMATOCRIT CNTL1980-07-14
K801268 — HEMOGLOBIN CONTROL LEVELS1980-07-14

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