510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904483Substantially Equivalent

Elegance Prolactin Elisa

Bioclone Australia Pty, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904483 is the FDA 510(k) clearance record for ELEGANCE PROLACTIN ELISA, a class I device, cleared for Bioclone Australia Pty , Ltd. on under FDA product code CFT (Radioimmunoassay, Prolactin (Lactogen)). FDA records list 10 510(k) clearances for Bioclone Australia Pty , Ltd., from to . As of , FDA records show no recalls naming K904483.

Clearance record

Decision date
Received
(34 days to decision)
Product code
CFT Radioimmunoassay, Prolactin (Lactogen)
Regulation
21 CFR 862.1625
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bioclone Australia Pty , Ltd. C/O Mackler & Gibbs, P.C., Washington DC
Third party review
No

Clearances, product code CFT

Trailing 12 months

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

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