Cleared Traditional

K921344 - THROMBO-CALIBRATOR KIT

K921344 is the FDA 510(k) clearance for THROMBO-CALIBRATOR KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K921344 · American Bioproducts Co. · Hematology device
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Jun 1992
Decision
82d
Days
Class 2
Risk

K921344 is an FDA 510(k) clearance for the THROMBO-CALIBRATOR KIT. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 American Bioproducts Co. devices

Submission Details

510(k) Number K921344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1992
Decision Date June 09, 1992
Days to Decision 82 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 113d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - GGN Plasma, Coagulation Control

All 55
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K921344.
COAGULATION A.R.P.
K933277 · Helena Laboratories · Mar 1994
CLIBRATION PLASMAS
K924404 · Behring Diagnostics, Inc. · Dec 1992
COAG-CONTROL [N] KIT
K922174 · American Bioproducts Co. · Oct 1992
COAGULATION ARPR,CAT.NO.5185
K914949 · Helena Laboratories · Mar 1992
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
K911777 · Helena Laboratories · Aug 1991
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
K905673 · Helena Laboratories · Feb 1991