510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JZTClass I

Fluorometer

21 CFR 866.4520 / Immunology
FDA source (opens on fda.gov)

JZT is the FDA product code for Fluorometer, a class I device type, regulated under 21 CFR 866.4520. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JZT
Device name
Fluorometer
Regulation
21 CFR 866.4520
Device class
Class I
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
0

Clearances, product code JZT

By decision year
14 clearances under product code JZT with a decision year between 1977 and 1996, 1984 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JZT by decision year
YearClearances
19771
19791
19801
19831
19843
19851
19863
19882
19961

Applicants with the most clearances

Product code JZT
Applicants holding the most 510(k) clearances under product code JZT
ApplicantClearances
Pandex Laboratories, Inc.2
Axonics, Inc.1
Bartels, Inc.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
California Immuno Diagnostic, Inc.1
Corning Medical & Scientific1
Dade, Baxter Travenol Diagnostics, Inc.1
Flow Laboratories, Inc.1
Hybritech, Inc.1
Intl. Diagnostic Technology1

Companies listing this code with FDA

Companies whose registered establishments list this code