Cleared Traditional

K852987 - CARIESCREEN - SM

K852987 is the FDA 510(k) clearance for CARIESCREEN - SM by Pharma-Medica of Scandinavia, Ltd.. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K852987 · Pharma-Medica of Scandinavia, Ltd. · Microbiology device
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Aug 1985
Decision
35d
Days
Class 1
Risk

K852987 is an FDA 510(k) clearance for the CARIESCREEN - SM. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Pharma-Medica of Scandinavia, Ltd. (Ontario L3r 2s2 Canada, CA). The FDA issued a Cleared decision on August 19, 1985 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Pharma-Medica of Scandinavia, Ltd. devices

Submission Details

510(k) Number K852987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date August 19, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 240
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