DADE RH CONTROL REAGENT— 510(k) K810599

Substantially Equivalent

American Dade

FDA 510(k) clearance K810599 for DADE RH CONTROL REAGENT, Substantially Equivalent on 1981-03-31. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code KSF
Device class: Class 2
Regulation: 21 CFR 864.9650
Advisory panel: Hematology
Date received: 1981-03-06
Decision date: 1981-03-31
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
K801425 — RH CONTROL1980-07-14
K800658 — RST-SERIES CONTROL1980-04-16
K800310 — ORTHO ANTISERA CONTROL1980-03-05
K800239 — RH-HR NEGATIVE CONTROL REAGENT1980-02-21

More clearances from American Dade

K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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