510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881435Substantially Equivalent

Pregnospia II

bioMerieux, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881435 is the FDA 510(k) clearance record for PREGNOSPIA II, a class II device, cleared for Organon Teknika Corp. on under FDA product code JHJ (Agglutination Method, Human Chorionic Gonadotropin). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K881435.

Clearance record

Decision date
Received
(52 days to decision)
Product code
JHJ Agglutination Method, Human Chorionic Gonadotropin
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Organon Teknika Corp. 800 Capitola Dr., Durham NC
Third party review
No

Clearances, product code JHJ

Trailing 12 months

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

FDA records show no clearances under product code JHJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JHJ, 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