Cleared Traditional

K812372 - GUINEA PIG BLOOD IN ALSEVER'S

K812372 is the FDA 510(k) clearance for GUINEA PIG BLOOD IN ALSEVER'S by Dutchland Laboratories, Inc.. It is a Class 1 Immunology device (product code LHT) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K812372 · Dutchland Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1981
Decision
20d
Days
Class 1
Risk

K812372 is an FDA 510(k) clearance for the GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF. Classified as Staphylococcus Aureus Somatic Antigens (product code LHT), Class I - General Controls.

Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3700 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dutchland Laboratories, Inc. devices

Submission Details

510(k) Number K812372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1981
Decision Date September 09, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHT Staphylococcus Aureus Somatic Antigens
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LHT Staphylococcus Aureus Somatic Antigens

All 8
Devices cleared under the same product code (LHT) and FDA review panel - the closest regulatory comparables to K812372.
ENDO-STAPH TEICHOIC ACID ANTIBODY KIT
K820531 · Meridian Diagnostics, Inc. · Apr 1982
GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD)
K812367 · Dutchland Laboratories, Inc. · Sep 1981
RAT BLOOD IN ALSEVER'S, CITRATED
K812368 · Dutchland Laboratories, Inc. · Sep 1981
RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR
K812373 · Dutchland Laboratories, Inc. · Sep 1981
ADULT CHICKEN BLOOD IN ALSEVER'S, C., D.
K812374 · Dutchland Laboratories, Inc. · Sep 1981
BABY CHICK BLOOD IN ALSEVER'S
K812375 · Dutchland Laboratories, Inc. · Sep 1981