Cleared Traditional

K842157 - TRIGLYCERIDE ASSAY KIT-COLORIMETRIC

K842157 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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May 1984
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K842157 is an FDA 510(k) clearance for the TRIGLYCERIDE ASSAY KIT-COLORIMETRIC.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Walker, US). The FDA issued a Cleared decision on May 30, 1984.

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.

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FDA 510(k) Submission Details - K842157

510(k) Number K842157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received May 30, 1984
Decision Date May 30, 1984
Days to Decision -
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -