Cleared Traditional

K883632 - EX-CELL 300TM

K883632 is the FDA 510(k) clearance for EX-CELL 300TM by J R Scientific. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K883632 · J R Scientific · Pathology device
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Sep 1988
Decision
16d
Days
Class 1
Risk

K883632 is an FDA 510(k) clearance for the EX-CELL 300TM, CATALOG NO. 210-3575. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by J R Scientific (Woodland, US). The FDA issued a Cleared decision on September 7, 1988 after a review of 16 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 J R Scientific devices

Submission Details

510(k) Number K883632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1988
Decision Date September 07, 1988
Days to Decision 16 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
61d faster than avg
Panel avg: 77d · This submission: 16d
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 K883632.
HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013
K883629 · J R Scientific · Sep 1988
RPMI-1640 MEDIUM, CATALOG NO. 210-3525
K883630 · J R Scientific · Sep 1988
EX-CELL 300TM, CATALOG # 210-3579
K883631 · J R Scientific · Sep 1988
SFRE 199-1 MEDIUM, CATALOG NO. 200-2191
K883451 · J R Scientific · Aug 1988
L-15 MEDIUM, CATALOG NO. 200-2021
K883362 · J R Scientific · Aug 1988
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105
K883363 · J R Scientific · Aug 1988