Cleared Traditional

K873084 - RPMI-1640 MEDIUM (HAT MODIFIED) NO. 200-2080

K873084 is an FDA 510(k) clearance for RPMI-1640 MEDIUM (HAT MODIFIED) NO. 200..., manufactured by J R Scientific. The device is a Class 1 Pathology device with product code KIT cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K873084 · J R Scientific · Pathology device
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Aug 1987
Decision
15d
Days
Class 1
Risk

K873084 is an FDA 510(k) clearance for the RPMI-1640 MEDIUM (HAT MODIFIED) NO. 200-2080. 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 August 21, 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 J R Scientific devices

FDA 510(k) Submission Details - K873084

510(k) Number K873084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1987
Decision Date August 21, 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.

KIT Device Classification - Class 1, General Controls

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 335
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K873084.
(MEM) EAGLE NO. M3024 W/EARLE'S SALTS
K873093 · Sigma Chemical Co. · Aug 1987
(MEM) EAGLE NO. M7399 W/EARLE'S SALTS
K873094 · Sigma Chemical Co. · Aug 1987
(MEM) EAGLE NO. M3149 W/HANKS' SALTS
K873095 · Sigma Chemical Co. · Aug 1987
WAYMOUTH 752/1 MEDIUM (MODIFIED) NO. 200-2085
K873085 · J R Scientific · Aug 1987
MINIMUM ESSENTIAL MEDIUM EAGLE(MEM ALPHA MODIFICA)
K873013 · J R Scientific · Aug 1987
NUTRIENT MIXTURE F-10 (HAM) CAT. # 200-2060
K873014 · J R Scientific · Aug 1987