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

Cyanomethemoglobin Reagent And Standard Solution

21 CFR 864.7500 / Hematology
FDA source (opens on fda.gov)

GJZ is the FDA product code for Cyanomethemoglobin Reagent And Standard Solution, a class II device type, regulated under 21 CFR 864.7500. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GJZ
Device name
Cyanomethemoglobin Reagent And Standard Solution
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code GJZ

By decision year
2 clearances under product code GJZ with a decision year between 1988 and 1988, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GJZ by decision year
YearClearances
19882

Applicants with the most clearances

Product code GJZ
Applicants holding the most 510(k) clearances under product code GJZ
ApplicantClearances
Abbott Diagnostics1
Tech-Co, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code