Cleared Traditional

'NO-BOIL' FOLIC ACID KIT (K810003) - FDA 510(k) Clearance

K810003 · Diagnostic Products Corp. · Chemistry device
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Jan 1981
Decision
15d
Days
-
Risk

K810003 is an FDA 510(k) clearance for the 'NO-BOIL' FOLIC ACID KIT.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1981 after a review of 15 days - a notably fast clearance 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: 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K810003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1981
Decision Date January 21, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -