Cleared Traditional

K822720 - MODEL 340 SPECTROPHOTOMETER

K822720 is an FDA 510(k) clearance for MODEL 340 SPECTROPHOTOMETER, manufactured by Abbott Diagnostics. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K822720 · Abbott Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1982
Decision
31d
Days
Class 1
Risk

K822720 is an FDA 510(k) clearance for the MODEL 340 SPECTROPHOTOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on October 8, 1982 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Abbott Diagnostics devices

FDA 510(k) Submission Details - K822720

510(k) Number K822720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1982
Decision Date October 08, 1982
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 165
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K822720.
COLORIMETERS SERIES ONE 12
K830101 · Innotron of Oregon, Inc. · Jan 1983
SPECTROPHOTOMETER
K823720 · Macomb Chemical Co. · Jan 1983
POSITIVE I.D. SYSTEM
K823266 · Abbott Laboratories · Dec 1982
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO
K822050 · Helena Laboratories · Aug 1982
MR 600 MICROPLATE READER
K821439 · Dynatech Corp. · Jun 1982
VERSACHEM ANALYZER
K821561 · Emd Chemicals, Inc. · Jun 1982