Cleared Traditional

K874179 - BIOTIS (TM) SABHI (DOUBLE POUR)

K874179 is an FDA 510(k) clearance for BIOTIS (TM) SABHI (DOUBLE POUR), manufactured by Otisville Biopharm, Inc.. The device is a Class 1 Microbiology device with product code KZI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K874179 · Otisville Biopharm, Inc. · Microbiology device
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Jan 1988
Decision
107d
Days
Class 1
Risk

K874179 is an FDA 510(k) clearance for the BIOTIS (TM) SABHI (DOUBLE POUR). Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by Otisville Biopharm, Inc. (Otisville, US). The FDA issued a Cleared decision on January 28, 1988 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2330 - 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 Otisville Biopharm, Inc. devices

FDA 510(k) Submission Details - K874179

510(k) Number K874179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date January 28, 1988
Days to Decision 107 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 102d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

KZI Device Classification - Class 1, General Controls

Product Code KZI Culture Media, Enriched
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2330
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 - KZI Culture Media, Enriched

All 38
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K874179.
CYSTINE TRYPTIC MEDIUM BASE
K880109 · Hardy Media · Mar 1988
WALLENSTEIN MEDIUM SLANT
K880138 · Hardy Media · Mar 1988
POTATO DEXTROSE AGAR
K880127 · Hardy Media · Mar 1988
MICRO CULTURE MEDIA P3141, P3136, P3148, P3748
K873952 · Lakewood Biochemical Co., Inc. · Oct 1987
SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD
K873320 · Lakewood Biochemical Co., Inc. · Sep 1987
SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300
K873321 · Lakewood Biochemical Co., Inc. · Sep 1987