Cleared Traditional

K915137 - KALLESTAD ROTAVIRUS MICROPLATE

K915137 is an FDA 510(k) clearance for KALLESTAD ROTAVIRUS MICROPLATE, manufactured by Bio-Rad Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LIQ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K915137 · Bio-Rad Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
112d
Days
Class 1
Risk

K915137 is an FDA 510(k) clearance for the KALLESTAD ROTAVIRUS MICROPLATE. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on March 4, 1992 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3405 - 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 Bio-Rad Laboratories, Inc. devices

FDA 510(k) Submission Details - K915137

510(k) Number K915137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1991
Decision Date March 04, 1992
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 102d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

LIQ Device Classification - Class 1, General Controls

Product Code LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
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 - LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus

All 27
Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K915137.
ROTA-DAN RAPID ROTAVIRUS EIA KIT
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DIARLEX ROTA-ADENO
K942286 · Orion Diagnostica, Inc. · Dec 1994
IMMUNOCARD ROTAVIRUS
K933587 · Meridian Diagnostics, Inc. · Feb 1994
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
K912666 · Dako Corp. · Feb 1992
SLIDEX ROTA-KIT 2
K895805 · Vitek Systems, Inc. · Feb 1991
ROTACUBE
K884017 · Difco Laboratories, Inc. · Jan 1989