Cleared Traditional

K872918 - GIT SERUM-FREE MEDIUM FOR CELL CULTURE

K872918 is the FDA 510(k) clearance for GIT SERUM-FREE MEDIUM FOR CELL CULTURE by Wako Chemicals USA, Inc.. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K872918 · Wako Chemicals USA, Inc. · Pathology device
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Aug 1987
Decision
15d
Days
Class 1
Risk

K872918 is an FDA 510(k) clearance for the GIT SERUM-FREE MEDIUM FOR CELL CULTURE. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on August 11, 1987 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2220 - the FDA pathology 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K872918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date August 11, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 77d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KIT Media And Components, Synthetic Cell And Tissue Culture

All 304
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K872918.
DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)
K873026 · J R Scientific · Aug 1987
MINIMUM ESSENTIAL MEDIUM EAGLE (MEM)CAT. #200-2045
K873027 · J R Scientific · Aug 1987
MINIMUM ESSENTIAL MEDIUM EAGLE(MEM ALPHA MODIFICA)
K873028 · J R Scientific · Aug 1987
DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)
K872465 · J R Scientific · Jul 1987
INTRA-ARTICULATED ARTHRO POWER SYSTEM
K871250 · Richard Wolf Medical Instruments Corp. · Apr 1987
(DMF/F-12) HYBRI-MAX(TM) W/L-GLUTAMINE
K871191 · Sigma Chemical Co. · Apr 1987