Cleared Traditional

K801578 - COMBOSTAT - NO-BOIL KIT

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

K801578 · Ria Products, Inc. · Hematology device
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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

FDA 510(k) Submission Details - K801578

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.

CDD Device Classification - Class 2, Special Controls

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 68
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
RIANEN, VITAMIN B12 ASSAY SYSTEM
K792175 · New England Nuclear · Nov 1979