Cleared Traditional

K870480 - NCTC 135 MEDIUM HYBRI-MAX W/L-GLUTAMINE...

K870480 is the FDA 510(k) clearance for NCTC 135 MEDIUM HYBRI-MAX W/L-GLUTAMINE... by Sigma Chemical Co.. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K870480 · Sigma Chemical Co. · Pathology device
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Mar 1987
Decision
55d
Days
Class 1
Risk

K870480 is an FDA 510(k) clearance for the NCTC 135 MEDIUM HYBRI-MAX W/L-GLUTAMINE #N5138. 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

Submission Details

510(k) Number K870480 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.

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 K870480.
HL-1 SUPPLEMENT
K870876 · Ventrex Laboratories, Inc. · Mar 1987
DULBECCO'S MOD. EAGLE MED. NUT. MIX. F-12 #D2906
K870478 · Sigma Chemical Co. · Mar 1987
(DME) HYBRI-MAX W/L-GLUTAMINE PRODUCT NO. D6780
K870479 · Sigma Chemical Co. · Mar 1987
(S-MEM) AUTO-MOD PRODUCT NO. M7272
K870481 · Sigma Chemical Co. · Mar 1987
WILLIAMS' MEDIUM E W/L-GLUTAMINE #W4125
K870483 · Sigma Chemical Co. · Mar 1987
LACTALBUMIN HYDROLYSATE (ELAH) NO. L3762
K870485 · Sigma Chemical Co. · Mar 1987