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

Stain, Fetal Hemoglobin

21 CFR 864.7455 / Hematology
FDA source (opens on fda.gov)

GHQ is the FDA product code for Stain, Fetal Hemoglobin, a class II device type, regulated under 21 CFR 864.7455. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GHQ
Device name
Stain, Fetal Hemoglobin
Regulation
21 CFR 864.7455
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
2
Ingested recalls
1

Clearances, product code GHQ

By decision year
2 clearances under product code GHQ with a decision year between 1989 and 1999, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GHQ by decision year
YearClearances
19891
19991

Applicants with the most clearances

Product code GHQ
Applicants holding the most 510(k) clearances under product code GHQ
ApplicantClearances
Caltag Laboratories, Inc.1
Sure-Tech Diagnostic Associates, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code