Cleared Traditional

K903638 - GASTRO-INTESTINAL ACCU-CULSHURE TM

K903638 is an FDA 510(k) clearance for GASTRO-INTESTINAL ACCU-CULSHURE TM, manufactured by Medical Laboratory Automation Systems, Inc.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K903638 · Medical Laboratory Automation Systems, Inc. · Microbiology device
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Jan 1991
Decision
158d
Days
Class 1
Risk

K903638 is an FDA 510(k) clearance for the GASTRO-INTESTINAL ACCU-CULSHURE TM. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 158 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 Medical Laboratory Automation Systems, Inc. devices

FDA 510(k) Submission Details - K903638

510(k) Number K903638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date January 18, 1991
Days to Decision 158 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 102d · This submission: 158d
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 33
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K903638.
CYTOQUANT COMBINED TRANSPORT MEDIA
K924053 · Proteins Intl., Inc. · Jan 1993
BACTI-SWAB(TM) NPG
K912832 · Remel Co. · Aug 1991
BACTI-SWAB(TM) II
K912831 · Remel Co. · Jul 1991
CHLAMYDIA ACCU-CULSHURE TM
K903405 · Medical Laboratory Automation Systems, Inc. · Oct 1990
VIRAL ACCU-CULSHURE TM
K903406 · Medical Laboratory Automation Systems, Inc. · Oct 1990
SPECIMEN CONTAINER
K896794 · Westmark, Sterile Packing Systems, Inc. (Sps) · Mar 1990