PARA-PAK SAF— 510(k) K792707

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K792707 for PARA-PAK SAF, Substantially Equivalent on 1980-01-21. Applicant: Meridian Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code IGG
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1979-12-27
Decision date: 1980-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IGG

K882268 — ZINC FORMALIN CONCENTRATE1988-06-15
K861201 — FORMALDEHYDE SOLUTION, 37%1986-04-11
K811794 — 37% FORMALDEHYDE1981-07-28
K802506 — PLEASCENT OR FORMA-SCENT1980-11-12
K792705 — PARA-PAK FORMALIN1980-01-21

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K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST1999-06-25
K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA1998-12-17

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