510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811370Substantially Equivalent

Natal-Tec Hpl

Armkel, LLC, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811370 is the FDA 510(k) clearance record for NATAL-TEC HPL, a class II device, cleared for Armkel, LLC on under FDA product code JMF (Radioimmunoassay, Human Placental Lactogen). FDA records list 68 510(k) clearances for Armkel, LLC, from to . As of , FDA records show no recalls naming K811370.

Clearance record

Decision date
Received
(15 days to decision)
Product code
JMF Radioimmunoassay, Human Placental Lactogen
Regulation
21 CFR 862.1585
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Armkel, LLC 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JMF

Trailing 12 months

FDA records hold no clearances under product code JMF in the trailing twelve months.

FDA records show no clearances under product code JMF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JMF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260