Cleared Traditional

K830252 - DIPCHEX DIP-SLIDE CULTURE SYS

K830252 is the FDA 510(k) clearance for DIPCHEX DIP-SLIDE CULTURE SYS by Granite Diagnostics, Inc.. It is a Class 1 Microbiology device (product code JXA) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K830252 · Granite Diagnostics, Inc. · Microbiology device
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Mar 1983
Decision
41d
Days
Class 1
Risk

K830252 is an FDA 510(k) clearance for the DIPCHEX DIP-SLIDE CULTURE SYS. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Granite Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1983 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Granite Diagnostics, Inc. devices

Submission Details

510(k) Number K830252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date March 07, 1983
Days to Decision 41 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
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXA Kit, Screening, Urine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JXA Kit, Screening, Urine

All 9
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K830252.
URICHECK
K860905 · Difco Laboratories, Inc. · Apr 1986
BAC-T-SCREEN
K851399 · Marion Laboratories, Inc. · Jun 1985
ORTHO BACTERIURIA DETECTION SYS
K833834 · Ortho Diagnostic Systems, Inc. · Mar 1984
BAC-T-SCREEN BACTERIURIA DETECTION DEV
K823850 · Marion Laboratories, Inc. · Mar 1983
MS-2 AUTOMATED URINE SCREENING SYSTEM
K781370 · Abbott Laboratories · Sep 1978
VAC-U-PAC KIDNEY CASSETTE
K781536 · E-Z-Em, Inc. · Sep 1978