Cleared Traditional

K934774 - UNKNOWN

K934774 is the FDA 510(k) clearance for UNKNOWN by Granbio, Inc.. It is a Class 1 Microbiology device (product code LSE) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K934774 · Granbio, Inc. · Microbiology device
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Apr 1994
Decision
197d
Days
Class 1
Risk

K934774 is an FDA 510(k) clearance for the UNKNOWN. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Granbio, Inc. (Temecula, US). The FDA issued a Cleared decision on April 20, 1994 after a review of 197 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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 Granbio, Inc. devices

Submission Details

510(k) Number K934774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1993
Decision Date April 20, 1994
Days to Decision 197 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 102d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LSE Epstein-barr Virus, Other
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
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 - LSE Epstein-barr Virus, Other

All 24
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K934774.
EBV LGG ELISA TEST
K941198 · Gull Laboratories, Inc. · Aug 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
K946157 · Incstar Corp. · Jun 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
K946159 · Incstar Corp. · Jun 1995
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
K931443 · Ortho Diagnostic Systems, Inc. · Nov 1993
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
K921628 · Incstar Corp. · Sep 1992
BARTELS EPSTEIN-BARR VIRUS IGG EIA
K922332 · Baxter Diagnostics, Inc. · Sep 1992