TRICHROME STAIN— 510(k) K831060

Substantially Equivalent

American Micro Scan

FDA 510(k) clearance K831060 for TRICHROME STAIN, Substantially Equivalent on 1983-06-08. Applicant: American Micro Scan. Device class: 1.

Clearance details

Applicant: American Micro Scan
Product code: Code JTS
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
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 JTS

K960090 — CALCOFLUOR WHITE STAIN KIT1996-03-19
K960095 — BACTIDROP CALCOFLUOR WHITE1996-03-19
K920970 — BACTIDROP KOH (10%)1992-06-09
K920975 — BACTIDROP CALCOFLUOR WHITE1992-06-09
K920976 — BACTIDROP INDIA INK1992-06-09

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.