Cleared Traditional

MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES & (K851738) - FDA 510(k) Clearance

Class I Hematology device.

K851738 · Sigma · Hematology device
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May 1985
Decision
20d
Days
Class 1
Risk

K851738 is an FDA 510(k) clearance for the MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Sigma (St. Louis, US). The FDA issued a Cleared decision on May 15, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.2220 - the FDA hematology 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 devices

Submission Details

510(k) Number K851738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date May 15, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 113d · This submission: 20d
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 366
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K851738.
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EARLE'S BALANCED SALTS W/OUT PHENOL RED & SODIUM
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MEDIUM 199 NO. M3274 W/HANKS' SALTS W.O/L-GLUTAMI.
K873090 · Sigma Chemical Co. · Aug 1987