BLOOD GROUP SUBSTANCE A— 510(k) K781862

Name: FDA 510(k) clearance K781862
Creator: U.S. Food and Drug Administration
Published: 1978-12-20

Substantially Equivalent

North American Biologicals, Inc.

FDA 510(k) clearance K781862 for BLOOD GROUP SUBSTANCE A, Substantially Equivalent on 1978-12-20. Applicant: North American Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: North American Biologicals, Inc.
Product code: Code KSX
Device class: Class 2
Regulation: 21 CFR 864.9160
Advisory panel: Hematology
Date received: 1978-11-06
Decision date: 1978-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KSX

view all

K802533 — GAMMA LEWIS BLOOD GROUP SUBSTANCE1980-11-12
K802534 — GAMMA PI BLOOD GROUP SUBSTANCE1980-11-12
K800916 — P1 BLOOD GROUP SUBSTANCE1980-05-08
K781895 — BLOOD GROUP SUBSTANCE B1978-12-20
K781896 — BLOOD GROUP SUBSTANCE A,B1978-12-20

More clearances from North American Biologicals, Inc.

view all

K820301 — PLASMA POOLER HEAT SEALER1982-04-09
K801219 — PLASMAPOOLER1980-10-31
K801425 — RH CONTROL1980-07-14

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