Cleared Traditional

MICRO ORGANISM GROWTH SYS-M1000 (K843000) - FDA 510(k) Clearance

Class I Microbiology device.

K843000 · Hml Inc/Biotechnology Transfer · Microbiology device
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Feb 1985
Decision
191d
Days
Class 1
Risk

K843000 is an FDA 510(k) clearance for the MICRO ORGANISM GROWTH SYS-M1000. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Hml Inc/Biotechnology Transfer (Cherry Hill, US). The FDA issued a Cleared decision on February 6, 1985 after a review of 191 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 Hml Inc/Biotechnology Transfer devices

Submission Details

510(k) Number K843000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1984
Decision Date February 06, 1985
Days to Decision 191 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 102d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 62
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K843000.
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NOVAPATH SPECIMEN COLLECTION KIT
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NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · Bio-Rad · May 1987
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
K843935 · Syva Co. · Oct 1984
COLLECTION KIT CHLAMYDIA TRACHOMATIS
K832079 · Syva Co. · Sep 1983