Cleared Traditional

K810002 - 'NO-BOIL' VITAMIN B12 KIT

K810002 is the FDA 510(k) clearance for 'NO-BOIL' VITAMIN B12 KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K810002 · Diagnostic Products Corp. · Chemistry device
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Jan 1981
Decision
10d
Days
Class 2
Risk

K810002 is an FDA 510(k) clearance for the 'NO-BOIL' VITAMIN B12 KIT. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1981 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - the FDA in vitro diagnostics and chemistry framework. 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 K810002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1981
Decision Date January 16, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 88d · This submission: 10d
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 Chemistry devices follow this clearance model.

Regulatory Peers - CDD Radioassay, Vitamin B12

All 49
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K810002.
NO-BOIL SOLID PHASE SIMUL TRAC B12
K822721 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1983
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
K830195 · Diagnostic Products Corp. · Feb 1983
NO-BOIL VITABIN B12 5760 FOLATE 125I
K813183 · Corning Medical & Scientific · Mar 1982
VITAMIN B12 (57CO) RADIOIMMUNOASSAY
K802220 · Corning Medical & Scientific · Jan 1981
CENTRIA VITAMIN B12 FOLATE RADIO SET
K791216 · Ventrex Laboratories, Inc. · Nov 1979
VITAMIN B12 RADIOASSAY
K780799 · Amersham Corp. · Jun 1978