Fuller Laboratories Mycoplasm Pneumonia Ifa-Igg Test

FDA 510(k) K931557 · Fuller Laboratories, Inc.

Substantially Equivalent

510(k) numberK931557

Submission

Device name
Fuller Laboratories Mycoplasm Pneumonia Ifa-Igg Test
Applicant
Fuller Laboratories, Inc.
Fullerton, CA, US
Received
March 30, 1993
Decision date
March 11, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GRZ – Antisera, Fluorescent, All, Mycoplasma Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3375
Specialty
Microbiology

Other 510(k)s with product code GRZ

510(k)DeviceApplicantDecision
K946373Mycoplasma Slurry and Mycoplasma Crowntitre Ifa Test SystemGRZ · Traditional Zeus Scientific, Inc.02/07/1996SE
K944417Zeua MycoplasmaGRZ · Traditional Zeus Scientific, Inc.08/01/1995SE
K861716Fiax Test Kit for Mycoplasma Pneumoniae-G AntibodyGRZ · Traditional Whittaker Bioproducts, Inc.08/08/1986SE
K840012Indirect Fluorescent Antibody MycoGRZ · Traditional Zeus Technologies02/27/1984SE

More from Zeus Technologies

510(k)DeviceDecision
K925690Meridian Ebna Test KitLLM · Traditional 10/12/1993SE
K925689Meridian Ebv-Igg Test KitMCD · Traditional 10/12/1993SE
K925688Meridian Ebv-Ea Test KitLSE · Traditional 10/12/1993SE

Questions and answers

When was Fuller Laboratories Mycoplasm Pneumonia Ifa-Igg Test cleared by the FDA?

Fuller Laboratories Mycoplasm Pneumonia Ifa-Igg Test (K931557) received a 510(k) decision of Substantially Equivalent on March 11, 1994, 346 days after the submission was received.

What is the product code of K931557?

The FDA product code is GRZ – Antisera, Fluorescent, All, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.