510(k) Report

510(k) · Cleared

Cleared

Amnio Stat-FLM Agglutination Test

K834616510(k) TraditionalCleared May 25, 1984163-day reviewClass II21 CFR 862.1455

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hana Biologics, Inc. · JHG Chromatographic Separation, Lecithin/Sphingomyelin Ratio

Cleared on May 25, 1984 after a 163-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 25, 1984
Review
163 days
Class
Class II
Product code
JHG
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K834616Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JHG devices

JHG Chromatographic Separation, Lecithin/Sphingomyelin Ratio: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JHG

FDA has decided no JHG device since 2007.

Median 510(k) review, days · JHG

Too few JHG 510(k)s in any year since 2007 to give a median.

Recalls per year · JHG

No recall names JHG since 2007.

Adverse event reports per year · JHG

No MAUDE report names JHG since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Hana Biologics, Inc.

8 FDA decisions under this applicant name. See the company

  • K883682Chang Medium (Additional Indications)Hana Biologics, Inc. · 1988
  • K855205Mycotrim TM VL Triphasic Culture SystemHana Biologics, Inc. · 1986
  • K833933Ace Color TestHana Biologics, Inc. · 1984
  • K822737Mycotrium-RSHana Biologics, Inc. · 1982
  • K822736Mycotrium-GUHana Biologics, Inc. · 1982

Recent decisions in JHG

The JHG category page

  • K061549Amniostat-FLM-PGIrvine Scientific Sales Co., Inc. · 2006
  • K871593TDXR Fetal Lung MaturityAbbott Laboratories · 1987
  • K822150Amnistat-FLMHana Biologics, Inc. · 1982
  • K813216Secure Fdi Test KitBeckman Instruments, Inc. · 1981
  • K811588Helena Fetal-Tek 200 MethodHelena Laboratories · 1981

https://510kreport.com/device/K834616 · printed Nov 4, 2026

Cite this page

510(k) Report. “K834616: Amnio Stat-FLM Agglutination Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K834616

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026