Cleared Traditional

K884797 - BERICHROM ALPHA-2-ANTIPLASMIN

K884797 is an FDA 510(k) clearance for BERICHROM ALPHA-2-ANTIPLASMIN, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K884797 · Behring Diagnostics, Inc. · Hematology device
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Apr 1989
Decision
156d
Days
Class 2
Risk

K884797 is an FDA 510(k) clearance for the BERICHROM ALPHA-2-ANTIPLASMIN. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on April 21, 1989 after a review of 156 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K884797

510(k) Number K884797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1988
Decision Date April 21, 1989
Days to Decision 156 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 113d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 135
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K884797.
ORTHOKROME* PLASMINOGEN
K900399 · Ortho Diagnostic Systems, Inc. · Mar 1990
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
K897136 · Helena Laboratories · Feb 1990
THE STAGO VIII DEFICIENT PLASMA KIT
K892859 · American Bioproducts Co. · Jun 1989
BERICHROM PROTEIN C KIT
K890634 · Behring Diagnostics, Inc. · Apr 1989
RELLPLATE C KIT, RELLPLATE C BULK PLATES
K884940 · American Diagnostic Corp. · Mar 1989
ACTICLOT C KIT
K884941 · American Diagnostic Corp. · Mar 1989