RH CONTROL— 510(k) K801425

Substantially Equivalent

North American Biologicals, Inc.

FDA 510(k) clearance K801425 for RH CONTROL, Substantially Equivalent on 1980-07-14. Applicant: North American Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: North American Biologicals, Inc.
Product code: Code KSF
Device class: Class 2
Regulation: 21 CFR 864.9650
Advisory panel: Hematology
Date received: 1980-06-17
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KSF

K811713 — AVI-D CONTROL1981-10-23
K810599 — DADE RH CONTROL REAGENT1981-03-31
K800658 — RST-SERIES CONTROL1980-04-16
K800310 — ORTHO ANTISERA CONTROL1980-03-05
K800239 — RH-HR NEGATIVE CONTROL REAGENT1980-02-21

More clearances from North American Biologicals, Inc.

K820301 — PLASMA POOLER HEAT SEALER1982-04-09
K801219 — PLASMAPOOLER1980-10-31
K781862 — BLOOD GROUP SUBSTANCE A1978-12-20
K781895 — BLOOD GROUP SUBSTANCE B1978-12-20
K781896 — BLOOD GROUP SUBSTANCE A,B1978-12-20

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