Cleared Traditional

VITAMIN B12 - NO-BOIL KIT (K801579) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801579 · Ria Products, Inc. · Hematology device
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Oct 1980
Decision
106d
Days
Class 2
Risk

K801579 is an FDA 510(k) clearance for the VITAMIN B12 - NO-BOIL KIT. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Ria Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1810 - the FDA hematology device framework. 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ria Products, Inc. devices

Submission Details

510(k) Number K801579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1980
Decision Date October 23, 1980
Days to Decision 106 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - CDD Radioassay, Vitamin B12

All 77
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