LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA— 510(k) K873186

Name: FDA 510(k) clearance K873186
Creator: U.S. Food and Drug Administration
Published: 1987-09-29

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K873186 for LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA, Substantially Equivalent on 1987-09-29. Applicant: Serono Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1987-08-12
Decision date: 1987-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEP

view all

K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE2003-01-16
K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST2002-11-05
K021409 — AT HOME OVULATION TEST, MODEL 90322002-05-24
K013874 — CLEARPLANE EASY OVULATION TEST2002-02-19
K013323 — TCI-31 LIFELONG OVULATION TESTER2001-12-05

More clearances from Serono Diagnostics, Inc.

view all

K953598 — SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS1996-03-11
K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY1994-07-13
K883085 — T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS1988-09-09
K882340 — LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA1988-08-08
K880388 — T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE1988-03-03

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