Cleared Traditional

K955561 - BUHLMANN VITAMIN B6 REA

K955561 is the FDA 510(k) clearance for BUHLMANN VITAMIN B6 REA by American Laboratory Products Co., Ltd.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K955561 · American Laboratory Products Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
169d
Days
Class 2
Risk

K955561 is an FDA 510(k) clearance for the BUHLMANN VITAMIN B6 REA. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by American Laboratory Products Co., Ltd. (Windham, US). The FDA issued a Cleared decision on May 23, 1996 after a review of 169 days - an extended review 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: 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 American Laboratory Products Co., Ltd. devices

Submission Details

510(k) Number K955561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1995
Decision Date May 23, 1996
Days to Decision 169 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 88d · This submission: 169d
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 56
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K955561.
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
K971177 · Diagnostic Products Corp. · May 1997
AXSYM B12
K965186 · Abbott Laboratories · Mar 1997
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
CEDIA VITAMIN B12 (NO BOIL) ASSAY
K951134 · Microgenics Corp. · Jul 1995