Cleared Traditional

K950801 - CARDIO REP LD CONTROL - CAT NO. 3325

K950801 is an FDA 510(k) clearance for CARDIO REP LD CONTROL - CAT NO. 3325, manufactured by Helena Laboratories. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K950801 · Helena Laboratories · Chemistry device
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Mar 1995
Decision
37d
Days
Class 1
Risk

K950801 is an FDA 510(k) clearance for the CARDIO REP LD CONTROL - CAT NO. 3325. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on March 30, 1995 after a review of 37 days - a notably fast clearance 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: 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 Helena Laboratories devices

FDA 510(k) Submission Details - K950801

510(k) Number K950801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date March 30, 1995
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
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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