NATAL-TEC HPL— 510(k) K811370

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K811370 for NATAL-TEC HPL, Substantially Equivalent on 1981-05-29. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code JMF
Device class: Class 2
Regulation: 21 CFR 862.1585
Advisory panel: Clinical Chemistry
Date received: 1981-05-14
Decision date: 1981-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMF

K944933 — IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)1995-03-10
K840588 — AMERLEX HUMAN PLACENTAL LACTOGEN1984-04-04
K823292 — IMMOPHASE TM HPL RADIOIMMUNOASSAY1982-12-28
K823201 — HUMAN PLACENTAL LACTOGEN KIT1982-11-29
K802454 — GESTE FOLLOW KIT DETERM. OF HPL1980-11-12

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.