Cleared Traditional

K842328 - AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN

K842328 is the FDA 510(k) clearance for AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN by Bartels Immunodiagnostic Supplies, Inc.. It is a Class 2 Immunology device (product code DEH) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K842328 · Bartels Immunodiagnostic Supplies, Inc. · Immunology device
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Aug 1984
Decision
51d
Days
Class 2
Risk

K842328 is an FDA 510(k) clearance for the AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Bartels Immunodiagnostic Supplies, Inc. (Walker, US). The FDA issued a Cleared decision on August 3, 1984 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Bartels Immunodiagnostic Supplies, Inc. devices

Submission Details

510(k) Number K842328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1984
Decision Date August 03, 1984
Days to Decision 51 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
53d faster than avg
Panel avg: 104d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEH Lambda, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 Immunology devices follow this clearance model.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 43
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