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

Hemoglobinometer

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

GIG is the FDA product code for Hemoglobinometer, a class II device type, regulated under 21 CFR 864.7500. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GIG
Device name
Hemoglobinometer
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
3
Ingested recalls
0

Clearances, product code GIG

By decision year
3 clearances under product code GIG with a decision year between 1977 and 1997, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GIG by decision year
YearClearances
19771
19941
19971

Applicants with the most clearances

Product code GIG
Applicants holding the most 510(k) clearances under product code GIG
ApplicantClearances
Artel, Inc.1
Randox Laboratories, Limited1
The Dow Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code