COAT-A-COUNT ESTRADIOL KIT— 510(k) K840051

Name: FDA 510(k) clearance K840051
Creator: U.S. Food and Drug Administration
Published: 1984-03-23

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K840051 for COAT-A-COUNT ESTRADIOL KIT, Substantially Equivalent on 1984-03-23. Applicant: Diagnostic Products Corp.. Device class: 1.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code CHP
Device class: Class 1
Regulation: 21 CFR 862.1260
Advisory panel: Clinical Chemistry
Date received: 1984-01-06
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHP

view all

K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM2004-09-24
K973901 — 17 B-ESTRADIOL (ELISA)1997-11-24
K973743 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER1997-10-31
K970386 — ACS ESTADIOL-6 II1997-06-04
K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)1997-03-18

More clearances from Diagnostic Products Corp.

view all

K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN2006-12-05
K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I2004-01-21
K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER2003-12-12
K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE2003-10-10
K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE2002-12-17

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