DADE ESR KIT— 510(k) K823368

Substantially Equivalent

American Dade

FDA 510(k) clearance K823368 for DADE ESR KIT, Substantially Equivalent on 1982-12-28. Applicant: American Dade. Device class: 1.

Clearance details

Applicant: American Dade
Product code: Code JPH
Device class: Class 1
Regulation: 21 CFR 864.6700
Advisory panel: Hematology
Date received: 1982-11-10
Decision date: 1982-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPH

K871076 — WINPETTE1987-03-23
K860899 — DISPETTE II1986-04-14
K852554 — SRT-SYSTEM1985-07-18
K840500 — SEDIPLAST1984-02-21
K831195 — WESTERGREN DISPETTE FOR ESR1983-05-09

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.