CRYPTOCOCCUS NEOFORMANS, ANTIGEN,— 510(k) K792691

Name: FDA 510(k) clearance K792691
Creator: U.S. Food and Drug Administration
Published: 1980-01-17

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K792691 for CRYPTOCOCCUS NEOFORMANS, ANTIGEN,, Substantially Equivalent on 1980-01-17. Applicant: Meridian Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code JWK
Device class: Class 2
Regulation: 21 CFR 866.3165
Advisory panel: Microbiology
Date received: 1979-12-27
Decision date: 1980-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

More clearances from Meridian Diagnostics, Inc.

view all

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

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