EBV IGM TEST— 510(k) K822734

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K822734 for EBV IGM TEST, Substantially Equivalent on 1982-12-09. Applicant: Gull Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code JRY
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1982-09-09
Decision date: 1982-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JRY

K042118 — ATHENA MULTI-LYTE EBV IGG TEST SYSTEM2005-04-29
K900974 — INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.1990-04-16
K891785 — BION EBV-G (VCA) TEST SYSTEM1989-08-31
K884829 — EBV EARLY ANTIGEN (R+D)1989-04-12
K822985 — EBV-M KIT1982-12-03

More clearances from Gull Laboratories, Inc.

K983541 — HSV 1+2 IGG ELISA TEST1999-02-26
K971857 — MUMPS IGG ELISA TESTY1997-11-04
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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