Cleared Traditional

K881995 - DIAMOND'S MEDIUM MODIFIED

K881995 is the FDA 510(k) clearance for DIAMOND'S MEDIUM MODIFIED by Remel Co.. It is a Class 1 Microbiology device (product code KZI) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K881995 · Remel Co. · Microbiology device
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Jun 1988
Decision
21d
Days
Class 1
Risk

K881995 is an FDA 510(k) clearance for the DIAMOND'S MEDIUM MODIFIED. Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on June 2, 1988 after a review of 21 days - a notably fast clearance cycle.

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: 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 Remel Co. devices

Submission Details

510(k) Number K881995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1988
Decision Date June 02, 1988
Days to Decision 21 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
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 29
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K881995.
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
K884208 · Oxoid U.S.A., Inc. · Oct 1988
MIDDLEBROOK 7H9 BROTH
K880122 · Hardy Media · Mar 1988
LOWENSTEIN-JENSEN, GRUFT
K880131 · Hardy Media · Mar 1988
MIDDLEBROOK 7H11 AGAR
K880134 · Hardy Media · Mar 1988
CYSTINE TRYPTIC MEDIUM BASE
K880109 · Hardy Media · Mar 1988
WALLENSTEIN MEDIUM SLANT
K880138 · Hardy Media · Mar 1988