Cleared Traditional

K833858 - COAGULASE PLASMA

K833858 is the FDA 510(k) clearance for COAGULASE PLASMA by Otisville Biotech, Inc.. It is a Class 1 Microbiology device (product code JTL) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K833858 · Otisville Biotech, Inc. · Microbiology device
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Dec 1983
Decision
31d
Days
Class 1
Risk

K833858 is an FDA 510(k) clearance for the COAGULASE PLASMA, HORSE & RABBIT EDTA. Classified as Plasma, Coagulase, Human, Horse And Rabbit (product code JTL), Class I - General Controls.

Submitted by Otisville Biotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2160 - the FDA microbiology 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 Otisville Biotech, Inc. devices

Submission Details

510(k) Number K833858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1983
Decision Date December 08, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 102d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTL Plasma, Coagulase, Human, Horse And Rabbit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2160
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 - JTL Plasma, Coagulase, Human, Horse And Rabbit

All 7
Devices cleared under the same product code (JTL) and FDA review panel - the closest regulatory comparables to K833858.
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
K870945 · Oxoid U.S.A., Inc. · Jun 1987
HEMASTAPH
K840553 · Remel Co. · Apr 1984
API STAPHASE III
K833988 · Analytical Products, Inc. · Dec 1983
RABBIT COAGULASE PLASMA
K812602 · Dutchland Laboratories, Inc. · Sep 1981
STAPHASE*
K811982 · Analytical Products, Inc. · Jul 1981
COAGULASE PLASMA
K792235 · Remel Co. · Dec 1979