DADE HEMATOLOGY CALIBRATOR PLUS— 510(k) K840010

Substantially Equivalent

American Dade

FDA 510(k) clearance K840010 for DADE HEMATOLOGY CALIBRATOR PLUS, Substantially Equivalent on 1984-04-19. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1984-01-04
Decision date: 1984-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code KRZ

K052101 — C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C2005-08-26
K041130 — CDS HEMATOLOGY CALIBRATOR (CDS CAL)2004-06-10
K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS1996-12-18
K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS1995-07-24
K902892 — CELL-DYN CALIBRATOR1990-09-10

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.