Cleared Traditional

K770526 - DIGITAL SCANNER

K770526 is an FDA 510(k) clearance for DIGITAL SCANNER, manufactured by The Perkin-Elmer Corp.. The device is a Class 1 Chemistry device with product code JXR cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K770526 · The Perkin-Elmer Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1977
Decision
21d
Days
Class 1
Risk

K770526 is an FDA 510(k) clearance for the DIGITAL SCANNER. Classified as Atomic Absorption Spectrophotometer, General Use (product code JXR), Class I - General Controls.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1977 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2850 - 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 The Perkin-Elmer Corp. devices

FDA 510(k) Submission Details - K770526

510(k) Number K770526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1977
Decision Date April 08, 1977
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

JXR Device Classification - Class 1, General Controls

Product Code JXR Atomic Absorption Spectrophotometer, General Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2850
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 - JXR Atomic Absorption Spectrophotometer, General Use

All 28
Devices cleared under the same product code (JXR) and FDA review panel - the closest regulatory comparables to K770526.
SPECTROPHOTOMETER, MODEL 751
K770645 · Instrumentation Laboratory CO · Jun 1977
SPECTROPHOTOMETER ANALYSIS SYS., AA-175
K770443 · Varian Assoc., Inc. · Apr 1977
SPECTROPHOTOMETER ANALYSIS SYS., AA-375
K770444 · Varian Assoc., Inc. · Apr 1977
ABSORPTION SPECTROPHOTOMETERS
K761316 · The Perkin-Elmer Corp. · Feb 1977
SAMPLER, FLAMELESS (IL MODEL 555)
K760119 · Instrumentation Laboratory CO · Jul 1976