DADE HEMATOLOGY CALIBRATOR— 510(k) K831140

Substantially Equivalent

American Dade

FDA 510(k) clearance K831140 for DADE HEMATOLOGY CALIBRATOR, Substantially Equivalent on 1983-06-08. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code KRX
Device class: Class 2
Regulation: 21 CFR 864.8150
Advisory panel: Hematology
Date received: 1983-04-07
Decision date: 1983-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRX

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.