Cleared Traditional

K983119 - ENTERO-TEST HP

K983119 is an FDA 510(k) clearance for ENTERO-TEST HP, manufactured by Hdc Corp.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K983119 · Hdc Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
188d
Days
Class 1
Risk

K983119 is an FDA 510(k) clearance for the ENTERO-TEST HP, MODEL #102-01. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Hdc Corp. (San Jose, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 188 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hdc Corp. devices

FDA 510(k) Submission Details - K983119

510(k) Number K983119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1998
Decision Date March 15, 1999
Days to Decision 188 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 102d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

LIO Device Classification - Class 1, General Controls

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - LIO Device, Specimen Collection

All 21
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