Cleared Traditional

K941797 - IMMULITE SHBG

K941797 is an FDA 510(k) clearance for IMMULITE SHBG, manufactured by Diagnostic Products Corp.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K941797 · Diagnostic Products Corp. · Chemistry device
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Oct 1994
Decision
202d
Days
Class 1
Risk

K941797 is an FDA 510(k) clearance for the IMMULITE SHBG. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 31, 1994 after a review of 202 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1680 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K941797

510(k) Number K941797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1994
Decision Date October 31, 1994
Days to Decision 202 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 88d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

CDZ Device Classification - Class 1, General Controls

Product Code CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1680
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 - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 67
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K941797.
IMMULITE SHBG (MODIFICATION)
K955440 · Diagnostic Products Corp. · Dec 1995
AURAFLEX TESTOSTERONE CALIBRATOR PACK
K951685 · Organon Teknika Corp. · Nov 1995
ACTIVE FREE TESTOSTERONE RIA
K952281 · Diagnostic Systems Laboratories, Inc. · Jul 1995
DELFIA SHBG KIT
K940449 · Wallac OY · Sep 1994
CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY
K934562 · Ciba Corning Diagnostics Corp. · Dec 1993
DELFIA TESTTOSTERONE KIT
K932951 · Wallac OY · Aug 1993