Cleared Traditional

K870488 - RPMI 1640 MEDIUM DEFI. MODIFICATION NO. R7130

K870488 is an FDA 510(k) clearance for RPMI 1640 MEDIUM DEFI. MODIFICATION NO...., manufactured by Sigma Chemical Co.. The device is a Class 1 Pathology device with product code KIT cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K870488 · Sigma Chemical Co. · Pathology device
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Mar 1987
Decision
55d
Days
Class 1
Risk

K870488 is an FDA 510(k) clearance for the RPMI 1640 MEDIUM DEFI. MODIFICATION NO. R7130. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on March 30, 1987 after a review of 55 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 Sigma Chemical Co. devices

FDA 510(k) Submission Details - K870488

510(k) Number K870488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date March 30, 1987
Days to Decision 55 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
22d faster than avg
Panel avg: 77d · This submission: 55d
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 K870488.
WILLIAMS' MEDIUM E W/L-GLUTAMINE #W4125
K870483 · Sigma Chemical Co. · Mar 1987
LACTALBUMIN HYDROLYSATE (ELAH) NO. L3762
K870485 · Sigma Chemical Co. · Mar 1987
H-Y MEDIUM (DME:NCTC109, 7:1 MIX.) HYBRI-MAX H9014
K870487 · Sigma Chemical Co. · Mar 1987
RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755
K870489 · Sigma Chemical Co. · Mar 1987
(DME) W/1000 MG GLUCOSE/L NO. D4655
K870490 · Sigma Chemical Co. · Mar 1987
DULBECCO'S MODIFIED EAGLE MEDIUM BASE NO. D5030
K870492 · Sigma Chemical Co. · Mar 1987