Cleared Traditional

K891869 - CLS 962 MICROPLATE PHOTOMETER

K891869 is an FDA 510(k) clearance for CLS 962 MICROPLATE PHOTOMETER, manufactured by Cambridge Life Sciences Plc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K891869 · Cambridge Life Sciences Plc. · Chemistry device
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May 1989
Decision
43d
Days
Class 1
Risk

K891869 is an FDA 510(k) clearance for the CLS 962 MICROPLATE PHOTOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Cambridge Life Sciences Plc. (Cambridge, England, GB). The FDA issued a Cleared decision on May 9, 1989 after a review of 43 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 Cambridge Life Sciences Plc. devices

FDA 510(k) Submission Details - K891869

510(k) Number K891869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1989
Decision Date May 09, 1989
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
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 166
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K891869.
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MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000)
K884782 · Dynatech Laboratories, Inc. · Feb 1989