Cleared Traditional

K955436 - ACCESS VITAMIN B12 ASSAY (MODIFICATION)

K955436 is the FDA 510(k) clearance for ACCESS VITAMIN B12 ASSAY (MODIFICATION) by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K955436 · Bio-Rad Laboratories, Inc. · Chemistry device
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Jan 1996
Decision
114d
Days
Class 2
Risk

K955436 is an FDA 510(k) clearance for the ACCESS VITAMIN B12 ASSAY (MODIFICATION). Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 114 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K955436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date January 24, 1996
Days to Decision 114 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
26d slower than avg
Panel avg: 88d · This submission: 114d
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 48
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K955436.
ELECSYS FOLATE
K973674 · Boehringer Mannheim Corp. · Nov 1997
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
K971177 · Diagnostic Products Corp. · May 1997
AXSYM B12
K965186 · Abbott Laboratories · Mar 1997
OPUS B12
K953455 · Behring Diagnostics, Inc. · Aug 1995
CEDIA VITAMIN B12 (NO BOIL) ASSAY
K951134 · Microgenics Corp. · Jul 1995
VISTA B12 ASSAY
K941235 · Syva Co. · Aug 1994