Cleared Traditional

PRECEPT CEFTAZIDIME

K862446 · Austin Biological Laboratories · Microbiology
Jul 1986
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K862446 is an FDA 510(k) clearance for the PRECEPT CEFTAZIDIME, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on July 11, 1986, 14 days after receiving the submission on June 27, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K862446 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1986
Decision Date July 11, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

Similar Devices — JWY Manual Antimicrobial Susceptibility Test Systems

All 438
MTS Aztreonam-Avibactam 0.016/4 - 256/4 ?g/mL
K252114 · Liofilchem S. R. L. · Oct 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
K252062 · Thermo Fisher Scientific · Sep 2025
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
K250575 · Thermo Fisher Scientific · Sep 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
K252014 · Thermo Fisher Scientific · Aug 2025
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 ?g/mL (SUD)
K251580 · Liofilchem S. R. L. · Aug 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
K250990 · Thermo Fisher Scientific · Jun 2025