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

Plasma, Control, Normal

21 CFR 864.5425 / Hematology
FDA source (opens on fda.gov)

GIZ is the FDA product code for Plasma, Control, Normal, a class II device type, regulated under 21 CFR 864.5425. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GIZ
Device name
Plasma, Control, Normal
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
20
Ingested recalls
1

Clearances, product code GIZ

By decision year
20 clearances under product code GIZ with a decision year between 1988 and 2007, 1989 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GIZ by decision year
YearClearances
19881
19894
19901
19921
19931
19943
19961
19971
19981
20001
20012
20021
20041
20071

Applicants with the most clearances

Product code GIZ
Applicants holding the most 510(k) clearances under product code GIZ
ApplicantClearances
Siemens Healthcare Diagnostics Inc.3
Analytical Control Systems2
Medical Diagnostic Technologies, Inc.2
Sigma Diagnostics, Inc.2
American Bioproducts Co.1
American Diagnostic Corp.1
Sekisui Diagnostics, LLC1
Behring Diagnostics, Inc.1
Cardiovascular Diagnostics, Inc.1
Creative Laboratory Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order