Cleared Traditional

ADVANCE C-REACTIVE PROTEIN (CRP) ASSAY (K821815) - FDA 510(k) Clearance

K821815 · Syva Co. · Immunology device
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Jun 1982
Decision
7d
Days
-
Risk

K821815 is an FDA 510(k) clearance for the ADVANCE C-REACTIVE PROTEIN (CRP) ASSAY.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Immunology 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: 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 Syva Co. devices

Submission Details

510(k) Number K821815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1982
Decision Date June 25, 1982
Days to Decision 7 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 104d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -