BLEEDING TIME DEVICE DISPOSABLE— 510(k) K830645

Substantially Equivalent

American Dade

FDA 510(k) clearance K830645 for BLEEDING TIME DEVICE DISPOSABLE, Substantially Equivalent on 1983-03-17. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code JCA
Device class: Class 2
Regulation: 21 CFR 864.6100
Advisory panel: Hematology
Date received: 1983-03-01
Decision date: 1983-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCA

K911745 — SIMPLATE PEDIATRIC1991-08-09
K911996 — SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION1991-07-17
K871318 — Q.I.C. BLEEDING TIME DEVICE1987-06-10
K850542 — SURGICUTT - BLEEDING TIME DEVICE1985-03-01
K801815 — AUTOLET1980-10-10

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.