SAF FIXATIVE— 510(k) K831058

Substantially Equivalent

American Micro Scan

FDA 510(k) clearance K831058 for SAF FIXATIVE, Substantially Equivalent on 1983-06-08. Applicant: American Micro Scan. Device class: 1.

Clearance details

Applicant: American Micro Scan
Product code: Code LDW
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1983-04-01
Decision date: 1983-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LDW

K883062 — ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID1988-08-04
K842923 — PICRIC ACID 1% W/V1984-09-11
K842922 — PICRIC ACID SATURATED SOLUTION1984-09-07

More clearances from American Micro Scan

K864662 — CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS1987-03-25
K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE1987-03-25
K863776 — MICRODILUTION MIC PANELS1987-02-02
K864674 — MICRODILUTION IDENTIFICATION PANELS1987-01-05
K864389 — CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST1986-12-04

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