Cleared Traditional

K801578 - COMBOSTAT - NO-BOIL KIT

K801578 is the FDA 510(k) clearance for COMBOSTAT - NO-BOIL KIT by Ria Products, Inc.. It is a Class 2 Hematology device (product code CDD) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K801578 · Ria Products, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
106d
Days
Class 2
Risk

K801578 is an FDA 510(k) clearance for the COMBOSTAT - 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 K801578 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 56
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K801578.
NO-BOIL VITABIN B12 5760 FOLATE 125I
K813183 · Corning Medical & Scientific · Mar 1982
'NO-BOIL' VITAMIN B12 KIT
K810002 · Diagnostic Products Corp. · Jan 1981
VITAMIN B12 (57CO) RADIOIMMUNOASSAY
K802220 · Corning Medical & Scientific · Jan 1981
CALBIOCHEM-BEHRING RIA-COUNT
K792460 · Calbiochem-Behring Corp. · Feb 1980
CENTRIA VITAMIN B12 FOLATE RADIO SET
K791216 · Ventrex Laboratories, Inc. · Nov 1979
AUTO PAK VITAMIN B-12
K790347 · Micromedic Systems · Sep 1979