Cleared Traditional

K962762 - SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR

K962762 is an FDA 510(k) clearance for SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR, manufactured by Biotraces, Inc.. The device is a Class 1 Chemistry device with product code JJJ cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K962762 · Biotraces, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
31d
Days
Class 1
Risk

K962762 is an FDA 510(k) clearance for the SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Biotraces, Inc. (Fairfax, US). The FDA issued a Cleared decision on August 16, 1996 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2320 - 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.

FDA 510(k) Submission Details - K962762

510(k) Number K962762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1996
Decision Date August 16, 1996
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 89d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

JJJ Device Classification - Class 1, General Controls

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 62
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K962762.
CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER
K946387 · Capintec, Inc. · Mar 1995
ABBOTT VERTEX ANALYZER
K920559 · Abbott Laboratories · Mar 1992
GENESYS 6000 GAMMA COUNTER
K900087 · Laboratory Technologies, Inc. · Jul 1990
MATRIX(TM)-96
K896202 · Canberra Industries, Inc. · Jan 1990
SOURCERER
K894902 · Oakfield Instruments, Ltd. · Oct 1989
SOURCERER
K884091 · John Caunt Scientific , Ltd. · Feb 1989
K962762 · SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
Download PDF FDA Summary Biotraces, Inc.