BIOFIX— 510(k) K843428

Substantially Equivalent

Accra Laboratories, Inc.

FDA 510(k) clearance K843428 for BIOFIX, Substantially Equivalent on 1984-09-27. Applicant: Accra Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Accra Laboratories, Inc.
Product code: Code LDZ
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1984-09-04
Decision date: 1984-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LDZ

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K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE1988-05-25
K881698 — ATS PVA FIXATIVE SOLUTION1988-05-13
K862725 — SACCOMANNO SPECIMAN SOLUTION1986-08-01
K842913 — WRIGHT STAIN FIXATIVE1984-09-07

More clearances from Accra Laboratories, Inc.

K851493 — KINYOUN ACID FAST STAIN KIT1985-04-29
K851494 — TWO-STEP ACID FAST BACTERIA STAIN1985-04-29
K843425 — HARRIS HEMATOXYLIN, MERCURY FREE, ACID1984-10-02
K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-61984-10-02
K843426 — EOSIN Y 1% ALCOHOLIC1984-09-27

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