Cleared Traditional

K955561 - BUHLMANN VITAMIN B6 REA

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

K955561 · American Laboratory Products Co., Ltd. · Chemistry device
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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

FDA 510(k) Submission Details - K955561

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.

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 Chemistry devices follow this clearance model.

Regulatory Peers - CDD Radioassay, Vitamin B12

All 67
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