Cleared Traditional

K800189 - BOVINE ALBUMIN 22% & 30% SOLUTIONS

K800189 is the FDA 510(k) clearance for BOVINE ALBUMIN 22% & 30% SOLUTIONS by Gotham Biologics, Inc.. It is a Class 2 Chemistry device (product code KSG) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800189 · Gotham Biologics, Inc. · Chemistry device
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Feb 1980
Decision
15d
Days
Class 2
Risk

K800189 is an FDA 510(k) clearance for the BOVINE ALBUMIN 22% & 30% SOLUTIONS. Classified as Media, Potentiating For In Vitro Diagnostic Use (product code KSG), Class II - Special Controls.

Submitted by Gotham Biologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.9600 - 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 Gotham Biologics, Inc. devices

Submission Details

510(k) Number K800189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1980
Decision Date February 13, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSG Media, Potentiating For In Vitro Diagnostic Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9600
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 - KSG Media, Potentiating For In Vitro Diagnostic Use

Devices cleared under the same product code (KSG) and FDA review panel - the closest regulatory comparables to K800189.
PENTEX BOVINE ALBUMIN 30% SOLUTION
K800943 · Miles Laboratories, Inc. · May 1980
LOW IONIC STRENGTH SOLUTION (LISS)
K791113 · Hyland Therapeutic Div., Travenol Laboratories · Jun 1979
DADE LOW IONIC STRENGTH SOLUITION (LISS)
K790776 · Dade, Baxter Travenol Diagnostics, Inc. · May 1979
LISS REAGENT
K790498 · Fisher Scientific Co., LLC · Apr 1979
LOW IIONIC STRENGTH SOLUTION
K780413 · Pfizer, Inc. · Apr 1978
SPECT RIM (LISS)
K780556 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1978