Cleared Traditional

K813563 - PHADEZYM ANALYZER

K813563 is the FDA 510(k) clearance for PHADEZYM ANALYZER by Pharmacia, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K813563 · Pharmacia, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1982
Decision
90d
Days
Class 1
Risk

K813563 is an FDA 510(k) clearance for the PHADEZYM ANALYZER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Pharmacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 22, 1982 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K813563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1981
Decision Date March 22, 1982
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 134
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K813563.
POSITIVE I.D. SYSTEM
K823266 · Abbott Laboratories · Dec 1982
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO
K822050 · Helena Laboratories · Aug 1982
VERSACHEM ANALYZER
K821561 · Emd Chemicals, Inc. · Jun 1982
4050/4051 ULTRASPEC
K820273 · Lkb Instruments, Inc. · Feb 1982
LKB-WALLACE 1251 LUMINOMETER
K820217 · Lkb Instruments, Inc. · Feb 1982
QUANTUMATIC DUAL-WAVELENGTH SPECTRO
K812865 · Abbott Laboratories · Nov 1981