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

Hemoglobin S

21 CFR 864.7415 / Hematology
FDA source (opens on fda.gov)

GIQ is the FDA product code for Hemoglobin S, a class II device type, regulated under 21 CFR 864.7415. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GIQ
Device name
Hemoglobin S
Regulation
21 CFR 864.7415
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
3
Ingested recalls
0

Clearances, product code GIQ

By decision year
3 clearances under product code GIQ with a decision year between 1988 and 1996, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GIQ by decision year
YearClearances
19881
19951
19961

Applicants with the most clearances

Product code GIQ
Applicants holding the most 510(k) clearances under product code GIQ
ApplicantClearances
Hf Scientific, Inc.1
Isolab, Inc.1
Medicus Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code