Cleared Traditional

K790347 - AUTO PAK VITAMIN B-12

K790347 is an FDA 510(k) clearance for AUTO PAK VITAMIN B-12, manufactured by Micromedic Systems. The device is a Class 2 Chemistry device with product code CDD cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K790347 · Micromedic Systems · Chemistry device
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Sep 1979
Decision
218d
Days
Class 2
Risk

K790347 is an FDA 510(k) clearance for the AUTO PAK VITAMIN B-12. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Micromedic Systems (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 218 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 Micromedic Systems devices

FDA 510(k) Submission Details - K790347

510(k) Number K790347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1979
Decision Date September 27, 1979
Days to Decision 218 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
130d slower than avg
Panel avg: 88d · This submission: 218d
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 K790347.
CALBIOCHEM-BEHRING RIA-COUNT
K792460 · Calbiochem-Behring Corp. · Feb 1980
CENTRIA VITAMIN B12 FOLATE RADIO SET
K791216 · Ventrex Laboratories, Inc. · Nov 1979
RIANEN, VITAMIN B12 ASSAY SYSTEM
K792175 · New England Nuclear · Nov 1979
VITAMIN B12 RADIOASSAY
K780799 · Amersham Corp. · Jun 1978
QUANTA-MATE VITAMIN B-12/FOLATE RA
K771047 · Bio-Rad · Jun 1977
VITAMIN B12 RADIOASSAY
K761321 · Kallestad Laboratories, Inc. · Mar 1977