Cleared Traditional

K850679 - TRYPSIN-EDTA SOLUTION

K850679 is the FDA 510(k) clearance for TRYPSIN-EDTA SOLUTION by Hazleton Research Products, Inc.. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K850679 · Hazleton Research Products, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
36d
Days
Class 1
Risk

K850679 is an FDA 510(k) clearance for the TRYPSIN-EDTA SOLUTION. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Hazleton Research Products, Inc. (Denver, US). The FDA issued a Cleared decision on March 29, 1985 after a review of 36 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 Hazleton Research Products, Inc. devices

Submission Details

510(k) Number K850679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1985
Decision Date March 29, 1985
Days to Decision 36 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
41d faster than avg
Panel avg: 77d · This submission: 36d
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 K850679.
MCDB 151 MEDIUM, PRODUCT NO. M6645
K851607 · Sigma Chemical Co. · May 1985
SFRE199-1 MEDIUM PRODUCT NO. S 2013
K851608 · Sigma Chemical Co. · May 1985
SFRE 199-2 MEDIUM, PRODUCTS NO. S2138
K851609 · Sigma Chemical Co. · May 1985
MCCOY'S 5A M9270 W/L-GLUTAMINE & W/O PHENOL RED &
K850890 · Sigma Chemical Co. · Mar 1985
DULBECCO'S MODIFIED EAGLE'S MEDIUM D7777, W/L-GLUT
K850891 · Sigma Chemical Co. · Mar 1985
MEM, M7270, W/EBSS, L-GLUTAMINE & W/O L-LEUCINE -
K850921 · Sigma Chemical Co. · Mar 1985