Cleared Traditional

K800816 - HIPPUR-ASE TUBES

K800816 is the FDA 510(k) clearance for HIPPUR-ASE TUBES by Microchemical Specialities, Co.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K800816 · Microchemical Specialities, Co. · Microbiology device
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Jul 1980
Decision
88d
Days
Class 1
Risk

K800816 is an FDA 510(k) clearance for the HIPPUR-ASE TUBES. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Microchemical Specialities, Co. (Mchenry, US). The FDA issued a Cleared decision on July 8, 1980 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Microchemical Specialities, Co. devices

Submission Details

510(k) Number K800816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1980
Decision Date July 08, 1980
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 149
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K800816.
API-CTS STREPTOCOCCUS
K801951 · Analytical Products, Inc. · Sep 1980
PORPHYRIN (ALA) DISK
K801492 · Remel Co. · Aug 1980
ALA SWAB
K801493 · Remel Co. · Aug 1980
AM-PEN SCREEN
K782086 · Pfizer, Inc. · Feb 1979
DISK, BETA-LACTAM
K790038 · Remel Co. · Jan 1979
API ZYM
K781567 · Analytical Products, Inc. · Dec 1978