Cleared Traditional

K851575 - DR. BRUNO LNAGE MINI PHOTOMETER

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

FDA 510(k) Submission Details - K851575

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 88d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -