510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061549Substantially Equivalent

Amniostat-Flm-Pg

FUJIFILM Biosciences Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061549 is the FDA 510(k) clearance record for AMNIOSTAT-FLM-PG, a class II device, cleared for Irvine Scientific Sales Co., Inc. on under FDA product code JHG (Chromatographic Separation, Lecithin/Sphingomyelin Ratio). FDA records list 45 510(k) clearances for FUJIFILM Biosciences INC., from to . As of , FDA records show no recalls naming K061549.

Clearance record

Decision date
Received
(135 days to decision)
Product code
JHG Chromatographic Separation, Lecithin/Sphingomyelin Ratio
Regulation
21 CFR 862.1455
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Irvine Scientific Sales Co., Inc. 2511 Daimler St., Santa Ana CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JHG

Trailing 12 months

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

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