E.COLI 0157 LATEX TEST— 510(k) K944421

Substantially Equivalent

Pro-Lab Diagnostics

FDA 510(k) clearance K944421 for E.COLI 0157 LATEX TEST, Substantially Equivalent on 1994-12-15. Applicant: Pro-Lab Diagnostics. Device class: 1.

Clearance details

Applicant: Pro-Lab Diagnostics
Product code: Code GMZ
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1994-08-18
Decision date: 1994-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Pro-Lab Diagnostics

K924328 — TRANSYSTEM LIQUID AMIES MEDIUM1992-12-24
K924329 — TRANSYSTEM AMIES W/O CHARCOAL1992-12-24
K924330 — TRANSYSTEM AMIES WITH CHARCOAL1992-12-24
K924331 — TRANSYSTEM LIQUID STUART MEDIUM1992-12-24

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