Cleared Traditional

K852568 - MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON

K852568 is an FDA 510(k) clearance for MCDB 201 MED CAT NO. M6770 W/ HEPES & W..., 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 24-day FDA review.

K852568 · Sigma Chemical Co. · Pathology device
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Jul 1985
Decision
24d
Days
Class 1
Risk

K852568 is an FDA 510(k) clearance for the MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON. 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 July 12, 1985 after a review of 24 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 - K852568

510(k) Number K852568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1985
Decision Date July 12, 1985
Days to Decision 24 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
53d faster than avg
Panel avg: 77d · This submission: 24d
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 K852568.
PENICILLIN/STREPTOMYCIN SOLUTION
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CELLGRO
K852288 · Mediatech, Inc. · Jun 1985
CRCM-30 MEDIUM PRODUCT NO. C5030
K851604 · Sigma Chemical Co. · May 1985