Cleared Traditional

K821623 - NOVA IV FLUIDS PACK & EXTERNAL STANDARDS

K821623 is the FDA 510(k) clearance for NOVA IV FLUIDS PACK & EXTERNAL STANDARDS by Shaban Mfg. Co.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K821623 · Shaban Mfg. Co. · Chemistry device
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Jun 1982
Decision
12d
Days
Class 2
Risk

K821623 is an FDA 510(k) clearance for the NOVA IV FLUIDS PACK & EXTERNAL STANDARDS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Shaban Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1982 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Shaban Mfg. Co. devices

Submission Details

510(k) Number K821623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1982
Decision Date June 14, 1982
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 201
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K821623.
GLUCOSE/UREA NITROGEN STANDARD
K822937 · Emd Chemicals, Inc. · Nov 1982
CO2/CI STANDARDS
K822289 · Gilford Diagnostics · Aug 1982
NOVA V FLUIDS PACK & EXTERNAL STANDARDS
K821794 · Shaban Mfg. Co. · Jul 1982
NOVA II FLUIDS PACK
K821030 · Shaban Mfg. Co. · May 1982
NOVA III FLUIDS PACK
K820947 · Shaban Mfg. Co. · Apr 1982
EXTERNAL STANDARDS-SODIUMNPOTASSIUM
K820700 · Shaban Mfg. Co. · Apr 1982