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

Giemsa Stain

21 CFR 864.1850 / Hematology
FDA source (opens on fda.gov)

HYF is the FDA product code for Giemsa Stain, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HYF
Device name
Giemsa Stain
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code HYF

By decision year
4 clearances under product code HYF with a decision year between 1983 and 1984, 1983 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HYF by decision year
YearClearances
19833
19841

Applicants with the most clearances

Product code HYF
Applicants holding the most 510(k) clearances under product code HYF
ApplicantClearances
J.S. Medical Assoc.2
Case Instruments1
E K Ind., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order