Cleared Traditional

K830308 - ULTRA ZYME PLUS GAMMA GT #65055 & 56

K830308 is the FDA 510(k) clearance for ULTRA ZYME PLUS GAMMA GT #65055 & 56 by Emd Chemicals, Inc.. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K830308 · Emd Chemicals, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1983
Decision
28d
Days
Class 1
Risk

K830308 is an FDA 510(k) clearance for the ULTRA ZYME PLUS GAMMA GT #65055 & 56. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1983 after a review of 28 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 K830308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1983
Decision Date February 28, 1983
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 K830308.
DART GAMMA-GT REAGENT SYSTEM
K834054 · Coulter Electronics, Inc. · Feb 1984
FLOW-PAC GGT REAGENT SET
K833029 · American Research Products Co. · Dec 1983
PARAMAX & GLUTAMYTRANSFERASE REAGENT
K833001 · American Dade · Oct 1983
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056
K830240 · 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