Cleared Traditional

K962407 - N/T PROTEIN CONTROL PY

K962407 is an FDA 510(k) clearance for N/T PROTEIN CONTROL PY, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GIL cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K962407 · Behring Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
38d
Days
Class 2
Risk

K962407 is an FDA 510(k) clearance for the N/T PROTEIN CONTROL PY. Classified as Plasma, Fibrinogen Control (product code GIL), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on July 29, 1996 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K962407

510(k) Number K962407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1996
Decision Date July 29, 1996
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 113d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIL Device Classification - Class 2, Special Controls

Product Code GIL Plasma, Fibrinogen Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
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 - GIL Plasma, Fibrinogen Control

All 7
Devices cleared under the same product code (GIL) and FDA review panel - the closest regulatory comparables to K962407.
FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3
K946193 · More Diagnostics · Aug 1995
FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
K946265 · Clinical Controls, Inc. · Aug 1995
PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
K935598 · Clinical Controls, Inc. · May 1995
N/T PROTEIN CONTROL PY
K951012 · Behring Diagnostics, Inc. · Apr 1995
LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2
K934741 · Clinical Controls, Inc. · Sep 1994
FIBRINOGEN CONTROL
K915462 · Sigma Diagnostics, Inc. · Mar 1992