Cleared Traditional

K855149 - COMPUTING SPECTROPHOTOMETER BIO-CHEMIST...

K855149 is the FDA 510(k) clearance for COMPUTING SPECTROPHOTOMETER BIO-CHEMIST... by Hyperion, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K855149 · Hyperion, Inc. · Chemistry device
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Feb 1986
Decision
47d
Days
Class 1
Risk

K855149 is an FDA 510(k) clearance for the COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Hyperion, Inc. (Miami, US). The FDA issued a Cleared decision on February 11, 1986 after a review of 47 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 Hyperion, Inc. devices

Submission Details

510(k) Number K855149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date February 11, 1986
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 135
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K855149.
THE PARTNER SPECTROPHOTOMETER
K861617 · Pharmacia, Inc. · May 1986
THE JR. PARTNER SPECTROPHOTOMETER
K861223 · Pharmacia, Inc. · May 1986
ULTROSPEC K KINETICS SPECTROPHOTOMETER
K861194 · Lkb Instruments, Inc. · Apr 1986
TERUMO SENSIBEAD EIA COLORIMETER
K854210 · Terumo Medical Corp. · Dec 1985
RAICHEM/K.E
K854540 · Reagents Applications, Inc. · Nov 1985
MR 700 MICROPLATE READER 012-700-1000
K854303 · Dynatech Laboratories, Inc. · Nov 1985