Cleared Traditional

K832892 - MODIFIED CHORIO-SHURE

K832892 is the FDA 510(k) clearance for MODIFIED CHORIO-SHURE by Nuclear Medical Laboratories, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K832892 · Nuclear Medical Laboratories, Inc. · Chemistry device
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Oct 1983
Decision
63d
Days
Class 2
Risk

K832892 is an FDA 510(k) clearance for the MODIFIED CHORIO-SHURE. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Nuclear Medical Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry 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 Nuclear Medical Laboratories, Inc. devices

Submission Details

510(k) Number K832892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1983
Decision Date October 28, 1983
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 187
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K832892.
STAR HCG MONOCLONAL ANTIBODY IMMUNORAD
K832796 · Syncor Intl. Corp. · Jan 1984
TANDEM R-TOTAL B-GCG KIT
K833194 · Hybritech, Inc. · Jan 1984
OREIA II B-HCG, ENZYME INNUNOASSAY
K832801 · Organon, Inc. · Dec 1983
BHCG RIA KIT
K831264 · Micromedic Systems · Jun 1983
ARIA II I-HCG
K830997 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1983
DUOCLON SLIDE TEST
K831109 · Organon, Inc. · Jun 1983