TOXO IGM TEST— 510(k) K880007

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K880007 for TOXO IGM TEST, Substantially Equivalent on 1988-03-17. Applicant: Gull Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code GLZ
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1988-01-04
Decision date: 1988-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GLZ

K924882 — TOXOPLASMA IGM IFA TEST SYSTEM1993-03-23
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K842664 — ANTI-TOXOPLASMA GONDII KIT1984-08-28
K832900 — IMMUNOENZYME TEST SYS-DETECT-IGM ANTI1983-11-14

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K940093 — EBV-EA(D) IGG ELISA TEST1995-09-15

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