RECAP— 510(k) K780665

Substantially Equivalent

Bca Biological Corp. of America

FDA 510(k) clearance K780665 for RECAP, Substantially Equivalent on 1978-06-06. Applicant: Bca Biological Corp. of America. Device class: 2.

Clearance details

Applicant: Bca Biological Corp. of America
Product code: Code KSF
Device class: Class 2
Regulation: 21 CFR 864.9650
Advisory panel: Hematology
Date received: 1978-04-21
Decision date: 1978-06-06
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
K801425 — RH CONTROL1980-07-14
K800658 — RST-SERIES CONTROL1980-04-16
K800310 — ORTHO ANTISERA CONTROL1980-03-05

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