Cleared Traditional

K850765 - STREP-KIT

K850765 is an FDA 510(k) clearance for STREP-KIT, manufactured by Culture Kits, Inc.. The device is a Class 1 Microbiology device with product code JSJ cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K850765 · Culture Kits, Inc. · Microbiology device
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Apr 1985
Decision
58d
Days
Class 1
Risk

K850765 is an FDA 510(k) clearance for the STREP-KIT. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Culture Kits, Inc. (Norwich, US). The FDA issued a Cleared decision on April 24, 1985 after a review of 58 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 Culture Kits, Inc. devices

FDA 510(k) Submission Details - K850765

510(k) Number K850765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1985
Decision Date April 24, 1985
Days to Decision 58 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 102d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

JSJ Device Classification - Class 1, General Controls

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 272
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K850765.
COLUMBIZ CNA AGAR W/5% SHEEP BLOOD
K851580 · Preferred Micro-Media · May 1985
GN BROTH
K851582 · Preferred Micro-Media · May 1985
MYCOLOGY AGAR W/ANTIBOTICS
K851590 · Preferred Micro-Media · Apr 1985
SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC
K851249 · Roche Diagnostic Systems, Inc. · Apr 1985
KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR
K851347 · Micro Media Laboratories · Apr 1985
COBA AGAR
K851348 · Micro Media Laboratories · Apr 1985