Cleared Traditional

K812380 - RABBIT SERUM - STERILE

K812380 is the FDA 510(k) clearance for RABBIT SERUM - STERILE by Dutchland Laboratories, Inc.. It is a Class 1 Pathology device (product code KIS) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K812380 · Dutchland Laboratories, Inc. · Pathology device
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Sep 1981
Decision
19d
Days
Class 1
Risk

K812380 is an FDA 510(k) clearance for the RABBIT SERUM - STERILE. Classified as Sera, Animal And Human (product code KIS), Class I - General Controls.

Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2800 - the FDA pathology 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 K812380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1981
Decision Date September 08, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 77d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIS Sera, Animal And Human
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2800
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 - KIS Sera, Animal And Human

All 20
Devices cleared under the same product code (KIS) and FDA review panel - the closest regulatory comparables to K812380.
GAMMA-FREE HORSE SERUM
K860762 · Flow Laboratories, Inc. · Mar 1986
FETAL BOVINE SERUM, F4884 STERILE GROWT
K843629 · Sigma Chemical Co. · Oct 1984
GUINEA PIG SERUM - STERILE
K812379 · Dutchland Laboratories, Inc. · Sep 1981
DONOR HORSE SERUM - STERILE
K812381 · Dutchland Laboratories, Inc. · Sep 1981
DONOR CALF (BOVINE-SERUM) - STERILE
K812382 · Dutchland Laboratories, Inc. · Sep 1981
CALF (BOVINE) SERUM - STERILE
K812383 · Dutchland Laboratories, Inc. · Sep 1981