RPR LIQUID CONTROLS— 510(k) K955143

Substantially Equivalent

Remel, L.P.

FDA 510(k) clearance K955143 for RPR LIQUID CONTROLS, Substantially Equivalent on 1996-07-30. Applicant: Remel, L.P.. Device class: 2.

Clearance details

Applicant: Remel, L.P.
Product code: Code GMP
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 1995-11-13
Decision date: 1996-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Augusta, GA, US

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More clearances from Remel, L.P.

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K964421 — REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK1996-12-06
K961046 — 10B ARGININE BROTH1996-09-18
K955136 — RPR CARD TEST KIT1996-07-29

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