OSOM MONO TEST 143— 510(k) K972231

Substantially Equivalent

Wyntek Diagnostics, Inc.

FDA 510(k) clearance K972231 for OSOM MONO TEST 143, Substantially Equivalent on 1997-08-26. Applicant: Wyntek Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Wyntek Diagnostics, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1997-06-16
Decision date: 1997-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTN

K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test2018-06-22
K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)2005-02-28
K030215 — BIORAPID MONONUCLEOSIS2003-02-24
K012901 — COLOR-MONOGEN2001-09-27
K982634 — DRYSPOT INFECTIOUS MONONUCLEOSIS KIT1999-01-28

More clearances from Wyntek Diagnostics, Inc.

K992658 — OSOM ULTRA STREP A TEST, MODEL 1472000-01-18
K990576 — OSOM CARD PREGNANCY TEST, MODEL 1031999-03-09
K990578 — OSOM CARD II HCG-URINE TEST, MODEL 1021999-03-09
K974159 — OSOM HCG-URINE TEST MODEL 1011997-12-24
K973879 — OSOM CARD HCG-URINE TEST1997-11-04

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