Cleared Traditional

K991843 - GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE

K991843 is an FDA 510(k) clearance for GREINER MINICOLLECT LITHIUM HEPARIN GEL..., manufactured by Greiner Meditech, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K991843 · Greiner Meditech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
28d
Days
Class 2
Risk

K991843 is an FDA 510(k) clearance for the GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Greiner Meditech, Inc. (Bel Air, US). The FDA issued a Cleared decision on June 25, 1999 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Greiner Meditech, Inc. devices

FDA 510(k) Submission Details - K991843

510(k) Number K991843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date June 25, 1999
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 144
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K991843.
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VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
K991551 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1999
GREINER VACUETTE BLOOD COLLECTION TUBE
K983952 · Greiner Meditech, Inc. · Dec 1998
TERUMO VENOJECT,LUER ADAPTER
K983490 · Terumo Corp. · Nov 1998
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
K983517 · Ram Scientific · Nov 1998