Cleared Traditional

K802923 - BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY

K802923 is an FDA 510(k) clearance for BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K802923 · Beckman Instruments, Inc. · Chemistry device
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Dec 1980
Decision
31d
Days
Class 2
Risk

K802923 is an FDA 510(k) clearance for the BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 19, 1980 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K802923

510(k) Number K802923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1980
Decision Date December 19, 1980
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. No clinical trials required.

CIC Device Classification - Class 2, Special Controls

Product Code CIC Cresolphthalein Complexone, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - CIC Cresolphthalein Complexone, Calcium

All 77
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K802923.
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K771831 · Gamma Enterprises, Inc. · Oct 1977