FPR THEOPHYLLINE KIT— 510(k) K894529

Substantially Equivalent

Colony Laboratories, Inc.

FDA 510(k) clearance K894529 for FPR THEOPHYLLINE KIT, Substantially Equivalent on 1989-09-15. Applicant: Colony Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Colony Laboratories, Inc.
Product code: Code LGS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1989-07-20
Decision date: 1989-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Colony Laboratories, Inc.

K894517 — FPR AMIKACIN KIT1989-09-28
K894518 — FPR AMIKACIN CALIBRATOR KIT1989-09-28
K894523 — FPR GENTAMICIN KIT1989-09-28
K894524 — FPR GENTAMICIN CALIBRATOR KIT1989-09-28
K894521 — FPR DIGOXIN KIT1989-09-25

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