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

Wright'S Stain

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

IAF is the FDA product code for Wright'S Stain, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IAF
Device name
Wright'S 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
33
Ingested recalls
0

Clearances, product code IAF

By decision year
33 clearances under product code IAF with a decision year between 1976 and 1989, 1979 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code IAF by decision year
YearClearances
19761
19772
19783
19795
19801
19814
19824
19835
19842
19852
19862
19892

Applicants with the most clearances

Product code IAF
Applicants holding the most 510(k) clearances under product code IAF
ApplicantClearances
Accra Laboratories, Inc.6
Mcb Manufacturing Chemists, Inc.3
Cambridge Chemical Products, Inc.2
E K Ind., Inc.2
EMD Millipore Corporation2
Jack W. Kindberg2
Mercedes Scientific Co., Inc.2
Sigma Diagnostics, Inc.2
Volu Sol Medical Industries2
Bioscientific1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order