Cleared Traditional

BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS (K870115) - FDA 510(k) Clearance

Class I Chemistry device.

K870115 · Berthold Analytical Instruments, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 1987
Decision
78d
Days
Class 1
Risk

K870115 is an FDA 510(k) clearance for the BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Berthold Analytical Instruments, Inc. (Nashua, US). The FDA issued a Cleared decision on March 31, 1987 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2320 - 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 Berthold Analytical Instruments, Inc. devices

Submission Details

510(k) Number K870115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1987
Decision Date March 31, 1987
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
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 - JJJ Counter (beta, Gamma) For Clinical Use

All 12
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K870115.
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