PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN— 510(k) K992717

Name: FDA 510(k) clearance K992717
Creator: U.S. Food and Drug Administration
Published: 1999-11-02

Substantially Equivalent

Pasco Laboratories, Inc.

FDA 510(k) clearance K992717 for PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN, Substantially Equivalent on 1999-11-02. Applicant: Pasco Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Pasco Laboratories, Inc.
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 1999-08-12
Decision date: 1999-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTN

view all

K262113 — HardyDisk AST Tebipenem 10µg (TBP10)2026-08-20
K261781 — Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ602026-07-24
K261853 — Gepotidacin GEP 10 µg2026-07-23
K260842 — HardyDisk AST Gepotidacin 10µg (GEP10)2026-05-11
K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP102025-12-05

More clearances from Pasco Laboratories, Inc.

view all

K042331 — PASCO MIC AND MIC/ID PANELS2004-10-07
K041776 — PASCO MIC AND MIC/ID PANELS2004-08-03
K041214 — PASCO MIC AND MIC/ID PANELS2004-06-07
K033119 — PASCO MIC AND MIC/ID PANELS2003-11-18
K031727 — PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN2003-07-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.