Cleared Traditional

K833988 - API STAPHASE III

K833988 is an FDA 510(k) clearance for API STAPHASE III, manufactured by Analytical Products, Inc.. The device is a Class 1 Microbiology device with product code JTL cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K833988 · Analytical Products, Inc. · Microbiology device
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Dec 1983
Decision
34d
Days
Class 1
Risk

K833988 is an FDA 510(k) clearance for the API STAPHASE III. Classified as Plasma, Coagulase, Human, Horse And Rabbit (product code JTL), Class I - General Controls.

Submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983 after a review of 34 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 Analytical Products, Inc. devices

FDA 510(k) Submission Details - K833988

510(k) Number K833988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1983
Decision Date December 22, 1983
Days to Decision 34 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
68d faster than avg
Panel avg: 102d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

JTL Device Classification - Class 1, General Controls

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 9
Devices cleared under the same product code (JTL) and FDA review panel - the closest regulatory comparables to K833988.
RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
K883333 · Immuno-Mycologics, Inc. · Aug 1988
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
K870945 · Oxoid U.S.A., Inc. · Jun 1987
HEMASTAPH
K840553 · Remel Co. · Apr 1984
COAGULASE PLASMA, HORSE & RABBIT EDTA
K833858 · Otisville Biotech, Inc. · Dec 1983
COAGULASE PLASMA-CITRATED & EDTA
K822988 · American Scientific Products · Nov 1982
RABBIT COAGULASE PLASMA
K812602 · Dutchland Laboratories, Inc. · Sep 1981