Cleared Traditional

K950803 - ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE

K950803 is an FDA 510(k) clearance for ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL T..., manufactured by Isolab, Inc.. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K950803 · Isolab, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
212d
Days
Class 1
Risk

K950803 is an FDA 510(k) clearance for the ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on September 21, 1995 after a review of 212 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Isolab, Inc. devices

FDA 510(k) Submission Details - K950803

510(k) Number K950803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date September 21, 1995
Days to Decision 212 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 88d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

JJT Device Classification - Class 1, General Controls

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJT Enzyme Controls (assayed And Unassayed)

All 80
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