Cleared Traditional

K781006 - IMMUNOCHEMISTRY SYS. MANUAL MODE

K781006 is an FDA 510(k) clearance for IMMUNOCHEMISTRY SYS. MANUAL MODE, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Immunology device with product code JZW cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K781006 · Beckman Instruments, Inc. · Immunology device
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Aug 1978
Decision
73d
Days
Class 1
Risk

K781006 is an FDA 510(k) clearance for the IMMUNOCHEMISTRY SYS. MANUAL MODE. Classified as Nephelometer (product code JZW), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1978 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4540 - the FDA immunology device 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 - K781006

510(k) Number K781006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1978
Decision Date August 31, 1978
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 104d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

JZW Device Classification - Class 1, General Controls

Product Code JZW Nephelometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4540
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 - JZW Nephelometer

All 9
Devices cleared under the same product code (JZW) and FDA review panel - the closest regulatory comparables to K781006.
RRT SYSTEM LASER REFLECTOMETER ANALYZER
K873407 · Incstar Corp. · Sep 1987
DISC 120 TRANSPORTER
K801391 · Travenol Laboratories, S.A. · Jul 1980
LANCER L-INA BUFFER, POLYMER, WASH SOLU
K792014 · Sherwood Medical Industries · Nov 1979
LASER STANDARD SERUM
K761235 · Behring Diagnostics, Inc. · Dec 1976
ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.
K761236 · Behring Diagnostics, Inc. · Dec 1976