Cleared Traditional

K830240 - ULTRAZYME PLUS GAMMA GT-MCA #65055-65056

K830240 is the FDA 510(k) clearance for ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 by Emd Chemicals, Inc.. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K830240 · Emd Chemicals, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1983
Decision
24d
Days
Class 1
Risk

K830240 is an FDA 510(k) clearance for the ULTRAZYME PLUS GAMMA GT-MCA #65055-65056. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on February 18, 1983 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1360 - the FDA in vitro diagnostics and chemistry 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K830240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date February 18, 1983
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQB Kinetic Method, Gamma-glutamyl Transpeptidase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1360
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 - JQB Kinetic Method, Gamma-glutamyl Transpeptidase

All 44
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K830240.
FLOW-PAC GGT REAGENT SET
K833029 · American Research Products Co. · Dec 1983
PARAMAX & GLUTAMYTRANSFERASE REAGENT
K833001 · American Dade · Oct 1983
ULTRA ZYME PLUS GAMMA GT #65055 & 56
K830308 · Emd Chemicals, Inc. · Feb 1983
ULTRAZYME PLUS GAMMA-GT, #64959/65032
K823883 · Emd Chemicals, Inc. · Jan 1983
ULTRAZYME PLUS GAMMA GT(65055-65056)
K820233 · Harleco · Feb 1982
ULTRAZYME-GT, ITEM #64959 & 65032
K813041 · Harleco · Nov 1981