510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
GLZClass II

Antigens, If, Toxoplasma Gondii

21 CFR 866.3780 / Microbiology
FDA source (opens on fda.gov)

GLZ is the FDA product code for Antigens, If, Toxoplasma Gondii, a class II device type, regulated under 21 CFR 866.3780. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GLZ
Device name
Antigens, If, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
18
Ingested recalls
0

Clearances, product code GLZ

By decision year
18 clearances under product code GLZ with a decision year between 1977 and 1993, 1979 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GLZ by decision year
YearClearances
19771
19782
19795
19801
19812
19832
19841
19852
19881
19931

Applicants with the most clearances

Product code GLZ
Applicants holding the most 510(k) clearances under product code GLZ
ApplicantClearances
Litton Bionetics3
Gull Laboratories, Inc.2
Intl. Diagnostic Technology2
Zeus Scientific LLC2
Amico Lab, Inc.1
Apple Diagnostic Products1
Bio-Rad1
Bionetic Laboratory Products1
Immuno-Diagnostic Products, Inc.1
Microbiological Assoc.1

Companies listing this code with FDA

Companies whose registered establishments list this code