510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834616Substantially Equivalent

Amnio Stat-Flm Agglutination Test

Hana Biologics, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834616 is the FDA 510(k) clearance record for AMNIO STAT-FLM AGGLUTINATION TEST, a class II device, cleared for Hana Biologics, Inc. on under FDA product code JHG (Chromatographic Separation, Lecithin/Sphingomyelin Ratio). FDA records list 8 510(k) clearances for Hana Biologics, Inc., from to . As of , FDA records show no recalls naming K834616.

Clearance record

Decision date
Received
(163 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
Hana Biologics, Inc. 4221 Richmond Rd., NW, Walker MI
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