ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII— 510(k) K844287

Name: FDA 510(k) clearance K844287
Creator: U.S. Food and Drug Administration
Published: 1985-01-07

Substantially Equivalent

Apple Diagnostic Products

FDA 510(k) clearance K844287 for ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII, Substantially Equivalent on 1985-01-07. Applicant: Apple Diagnostic Products. Device class: 2.

Clearance details

Applicant: Apple Diagnostic Products
Product code: Code GLZ
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1984-11-05
Decision date: 1985-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pipersille, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GLZ

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K924882 — TOXOPLASMA IGM IFA TEST SYSTEM1993-03-23
K880007 — TOXO IGM TEST1988-03-17
K850591 — FIAX TOXO-M ANTIBODIES TEST KIT1985-04-30
K842664 — ANTI-TOXOPLASMA GONDII KIT1984-08-28
K832900 — IMMUNOENZYME TEST SYS-DETECT-IGM ANTI1983-11-14

More clearances from Apple Diagnostic Products

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K843745 — ADP ANA APPLEZYME1984-10-25
K843120 — APPLELISA CHLAMYDIA TRACHOMATIS ANTI1984-09-12
K842707 — ADP NDNA IFA TEST1984-08-21
K842183 — ADP ANA IFA TEST1984-06-22
K834241 — ANA APPLELISA1984-04-04

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