PREGNASLIDE— 510(k) K863198

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K863198 for PREGNASLIDE, Substantially Equivalent on 1986-09-29. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1986-08-19
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHJ

K972606 — PREGNACOL PREGNANCY TEST1997-08-29
K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST1996-06-28
K935863 — SAS(TM) DIRECT MONOCLONAL HCG1994-02-24
K926112 — ACCUTEX BETA-HCG TEST1993-07-28
K930609 — SAS(TM) MONOCLONAL HCG-SLIDE1993-03-29

More clearances from Armkel, LLC

K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST2004-10-19
K030258 — FIRST RESPONSE PREGNANCY TEST2003-02-25
K023405 — TROJAN MINT TINGLE BRAND LATEX CONDOMS2002-12-16
K013433 — TROJAN PASSION BERRY GEL2002-03-05
K013614 — TROJAN CRYSTAL CLEAR LIQUID2002-02-01

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