PARA-PAK FORMALIN— 510(k) K792705

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K792705 for PARA-PAK FORMALIN, 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
K792707 — PARA-PAK SAF1980-01-21

More clearances from Meridian Diagnostics, Inc.

K993914 — PREMIER TOXINS A&B, MODEL 6160961999-12-10
K990263 — IMMUNOCARD STAT! E. COLI O157:H71999-08-09
K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST1999-06-25
K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST1999-06-25
K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA1998-12-17

Recalls naming K792705

K-number listed on FDA's recall record

Z-0520-2024 — Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012Class II·Ongoing·Meridian Bioscience Inc·20231019

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K792705.

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