Cleared Traditional

DR. BRUNO LNAGE MINI PHOTOMETER (K851575) - FDA 510(k) Clearance

K851575 · Texas Medical Products, Inc. · Chemistry device
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Oct 1985
Decision
184d
Days
-
Risk

K851575 is an FDA 510(k) clearance for the DR. BRUNO LNAGE MINI PHOTOMETER.

Submitted by Texas Medical Products, Inc. (Houston, US). The FDA issued a Cleared decision on October 18, 1985 after a review of 184 days - an extended review cycle.

This device falls under the Chemistry FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Texas Medical Products, Inc. devices

Submission Details

510(k) Number K851575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1985
Decision Date October 18, 1985
Days to Decision 184 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 88d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -