Cleared Traditional

K903405 - CHLAMYDIA ACCU-CULSHURE TM

K903405 is an FDA 510(k) clearance for CHLAMYDIA 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 77-day FDA review.

K903405 · Medical Laboratory Automation Systems, Inc. · Microbiology device
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Oct 1990
Decision
77d
Days
Class 1
Risk

K903405 is an FDA 510(k) clearance for the CHLAMYDIA 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 October 16, 1990 after a review of 77 days - a notably fast clearance 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: 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 Medical Laboratory Automation Systems, Inc. devices

FDA 510(k) Submission Details - K903405

510(k) Number K903405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date October 16, 1990
Days to Decision 77 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
25d faster than avg
Panel avg: 102d · This submission: 77d
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 K903405.
BACTI-SWAB(TM) NPG
K912832 · Remel Co. · Aug 1991
BACTI-SWAB(TM) II
K912831 · Remel Co. · Jul 1991
GASTRO-INTESTINAL ACCU-CULSHURE TM
K903638 · Medical Laboratory Automation Systems, Inc. · Jan 1991
VIRAL ACCU-CULSHURE TM
K903406 · Medical Laboratory Automation Systems, Inc. · Oct 1990
SPECIMEN CONTAINER
K896794 · Westmark, Sterile Packing Systems, Inc. (Sps) · Mar 1990
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · Diagnostic Products Corp. · Aug 1989