Cleared Traditional

K853691 - TERGITOL 7 AGAR

K853691 is an FDA 510(k) clearance for TERGITOL 7 AGAR, manufactured by Micro Media Laboratories. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K853691 · Micro Media Laboratories · Microbiology device
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Sep 1985
Decision
13d
Days
Class 1
Risk

K853691 is an FDA 510(k) clearance for the TERGITOL 7 AGAR. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on September 17, 1985 after a review of 13 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.

FDA 510(k) Submission Details - K853691

510(k) Number K853691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date September 17, 1985
Days to Decision 13 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
89d faster than avg
Panel avg: 102d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

JSI Device Classification - Class 1, General Controls

Product Code JSI Culture Media, Selective And 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 - JSI Culture Media, Selective And Differential

All 284
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K853691.
HEKTOEN ENTERIC AGAR
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K854450 · R. Kent Richards, Inc. · Nov 1985
MANNITOL SALT AGAR
K854452 · R. Kent Richards, Inc. · Nov 1985
APL SIMMONS CITRATE AGAR
K853617 · Apl Medical Supplies · Sep 1985
APL XYLOSE LYSINE DEOXYCHOLATE AGAR
K853611 · Apl Medical Supplies · Sep 1985
STAPH KIT
K853488 · Culture Kits, Inc. · Aug 1985
K853691 · TERGITOL 7 AGAR
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