Cleared Traditional

K780903 - CLINICAL ANALYZER SYSTEM

K780903 is the FDA 510(k) clearance for CLINICAL ANALYZER SYSTEM by Bausch & Lomb, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K780903 · Bausch & Lomb, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1978
Decision
28d
Days
Class 1
Risk

K780903 is an FDA 510(k) clearance for the CLINICAL ANALYZER SYSTEM. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1978 after a review of 28 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 Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K780903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1978
Decision Date June 28, 1978
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 99
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K780903.
MINI-KEM
K781576 · Coulter Electronics, Inc. · Oct 1978
SPECTROPHOTOMETER
K781138 · Bausch & Lomb, Inc. · Aug 1978
FISHER SPECTROPHOTOMETER
K780902 · Bausch & Lomb, Inc. · Jun 1978
DUAL WAVELENGTH PHOTOMETER, 1177
K771909 · Abbott Laboratories · Dec 1977
SPECTROPHOTOMETER ANALYSIS SYS.
K771807 · Varian Assoc., Inc. · Nov 1977
SPECTROPHOTOMETER CARY 219
K772022 · Varian Assoc., Inc. · Nov 1977