Cleared Traditional

K770645 - SPECTROPHOTOMETER

K770645 is the FDA 510(k) clearance for SPECTROPHOTOMETER by Instrumentation Laboratory CO. It is a Class 1 Toxicology device (product code JXR) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K770645 · Instrumentation Laboratory CO · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1977
Decision
80d
Days
Class 1
Risk

K770645 is an FDA 510(k) clearance for the SPECTROPHOTOMETER, MODEL 751. Classified as Atomic Absorption Spectrophotometer, General Use (product code JXR), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on June 24, 1977 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2850 - the FDA toxicology 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K770645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1977
Decision Date June 24, 1977
Days to Decision 80 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 87d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K770645.
SPECTROPHOTOMETER, MODEL 5000
K780112 · The Perkin-Elmer Corp. · Jan 1978
SPECTROPHOTOMETER - SERIES AA-575
K772165 · Varian Assoc., Inc. · Nov 1977
SPECTROPHOTOMETEO IL MODEL 651
K771604 · Instrumentation Laboratory CO · Sep 1977
SPECTROPHOTOMETER ANALYSIS SYS., AA-175
K770443 · Varian Assoc., Inc. · Apr 1977
SPECTROPHOTOMETER ANALYSIS SYS., AA-375
K770444 · Varian Assoc., Inc. · Apr 1977
DIGITAL SCANNER
K770526 · The Perkin-Elmer Corp. · Apr 1977