Cleared Traditional

K882173 - DELFIA ESTRADIOL KIT

K882173 is an FDA 510(k) clearance for DELFIA ESTRADIOL KIT, manufactured by Pharmacia, Inc.. The device is a Class 1 Chemistry device with product code CHP cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K882173 · Pharmacia, Inc. · Chemistry device
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Jun 1988
Decision
31d
Days
Class 1
Risk

K882173 is an FDA 510(k) clearance for the DELFIA ESTRADIOL KIT. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on June 24, 1988 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 Pharmacia, Inc. devices

FDA 510(k) Submission Details - K882173

510(k) Number K882173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1988
Decision Date June 24, 1988
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

CHP Device Classification - Class 1, General Controls

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
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 - CHP Radioimmunoassay, Estradiol

All 42
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K882173.
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
K890645 · Serono-Baker Diagnostics, Inc. · Mar 1989
AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)
K884105 · Amersham Corp. · Nov 1988
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
K882343 · Terumo Medical Corp. · Jul 1988
DSL ACTIVE ESTRADIOL RIA (DSL #4300)
K873550 · Diagnostic Systems Laboratories, Inc. · Feb 1988
DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)
K870405 · Diagnostic Systems Laboratories, Inc. · Jun 1987
DOUBLE ANTIBODY ESTRADIOL RIA KIT
K862603 · Diagnostic Products Corp. · Aug 1986