Cleared Traditional

K951134 - CEDIA VITAMIN B12 (NO BOIL) ASSAY

K951134 is the FDA 510(k) clearance for CEDIA VITAMIN B12 (NO BOIL) ASSAY by Microgenics Corp.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K951134 · Microgenics Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
120d
Days
Class 2
Risk

K951134 is an FDA 510(k) clearance for the CEDIA VITAMIN B12 (NO BOIL) ASSAY. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Microgenics Corp. devices

Submission Details

510(k) Number K951134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date July 11, 1995
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 88d · This submission: 120d
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 55
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K951134.
AIA-PACK B12 ASSAY
K964348 · Tosoh Medics, Inc. · Jan 1997
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
K955436 · Bio-Rad Laboratories, Inc. · Jan 1996
OPUS B12
K953455 · Behring Diagnostics, Inc. · Aug 1995
VISTA B12 ASSAY
K941235 · Syva Co. · Aug 1994
ACCESS VITAMIN B12 ASSAY
K933142 · Bio-Rad Laboratories, Inc. · Nov 1993
RADIAS B12 ENZYME IMMUNOASSAY
K933315 · Bio-Rad · Aug 1993