BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY— 510(k) K883305

Name: FDA 510(k) clearance K883305
Creator: U.S. Food and Drug Administration
Published: 1988-10-06

Substantially Equivalent

Binax, Inc.

FDA 510(k) clearance K883305 for BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY, Substantially Equivalent on 1988-10-06. Applicant: Binax, Inc.. Device class: 1.

Clearance details

Applicant: Binax, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1988-08-04
Decision date: 1988-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S. Portland, ME, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGJ

view all

K052662 — ONE STEP FSH MENOPAUSAL TEST2005-11-30
K043599 — MOMENTS MENOPAUSE CHECK, MODEL 91132005-02-25
K041165 — FSH MENOPAUSE PREDICTOR TEST2004-06-17
K040575 — PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 91122004-05-20
K030058 — EARLYDETECT MENOPAUSE TEST FOR FSH2003-07-30

More clearances from Binax, Inc.

view all

K090301 — BINAXNOW PBP2A TEST, MODEL 890-0002010-04-14
K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-0002010-02-24
K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST2009-12-16
K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-4302009-09-04
K083744 — BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-0102009-09-01

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