TOXO TEST— 510(k) K772243

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K772243 for TOXO TEST, Substantially Equivalent on 1977-12-22. 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: 1977-12-08
Decision date: 1977-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GLZ

K924882 — TOXOPLASMA IGM IFA TEST SYSTEM1993-03-23
K880007 — TOXO IGM TEST1988-03-17
K850591 — FIAX TOXO-M ANTIBODIES TEST KIT1985-04-30
K844287 — ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII1985-01-07
K842664 — ANTI-TOXOPLASMA GONDII KIT1984-08-28

More clearances from Gull Laboratories, Inc.

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K962343 — TOXO IGG ELISA TEST1997-03-24
K935730 — EBNA IGG ELISA TEST1995-09-19
K940093 — EBV-EA(D) IGG ELISA TEST1995-09-15

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