Cleared Traditional

K822150 - AMNISTAT-FLM

K822150 is the FDA 510(k) clearance for AMNISTAT-FLM by Hana Biologics, Inc.. It is a Class 2 Hematology device (product code JHG) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K822150 · Hana Biologics, Inc. · Hematology device
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Oct 1982
Decision
91d
Days
Class 2
Risk

K822150 is an FDA 510(k) clearance for the AMNISTAT-FLM. Classified as Chromatographic Separation, Lecithin/sphingomyelin Ratio (product code JHG), Class II - Special Controls.

Submitted by Hana Biologics, Inc. (Walker, US). The FDA issued a Cleared decision on October 21, 1982 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1455 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hana Biologics, Inc. devices

Submission Details

510(k) Number K822150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1982
Decision Date October 21, 1982
Days to Decision 91 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 113d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHG Chromatographic Separation, Lecithin/sphingomyelin Ratio
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1455
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JHG Chromatographic Separation, Lecithin/sphingomyelin Ratio

Devices cleared under the same product code (JHG) and FDA review panel - the closest regulatory comparables to K822150.
AMNIOSTAT-FLM-PG
K061549 · Irvine Scientific Sales Co., Inc. · Oct 2006
TDXR FETAL LUNG MATURITY
K871593 · Abbott Laboratories · Jul 1987
SECURE FDI TEST KIT
K813216 · Beckman Instruments, Inc. · Dec 1981
HELENA FETAL-TEK 200 METHOD
K811588 · Helena Laboratories · Jun 1981
FETAL MATURITY TEST PROCEDURE
K790798 · Helena Laboratories · Jun 1979