PROSPECT GIARDIA— 510(k) K942098

Substantially Equivalent

Alexon, Inc.

FDA 510(k) clearance K942098 for PROSPECT GIARDIA, Substantially Equivalent on 1994-09-09. Applicant: Alexon, Inc.. Device class: 2.

Clearance details

Applicant: Alexon, Inc.
Product code: Code MHI
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1994-04-14
Decision date: 1994-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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More clearances from Alexon, Inc.

K934493 — PROSPECT MICROPLATE ASSAY1994-09-20
K931147 — PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION1993-05-13
K930451 — PROSPEC T GIARDIA MICROTITER ASSAY1993-04-21
K922675 — PROSPECT GIARDIA CONTROLS1992-09-11
K922010 — PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION1992-06-19

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