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

Stain, Papanicolau

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

HZJ is the FDA product code for Stain, Papanicolau, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HZJ
Device name
Stain, Papanicolau
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
15
Ingested recalls
2

Clearances, product code HZJ

By decision year
15 clearances under product code HZJ with a decision year between 1978 and 1984, 1984 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code HZJ by decision year
YearClearances
19783
19802
19812
19822
19846

Applicants with the most clearances

Product code HZJ
Applicants holding the most 510(k) clearances under product code HZJ
ApplicantClearances
E K Ind., Inc.4
Bioscientific3
Surgipath3
Volu Sol Medical Industries3
Accra Laboratories, Inc.1
Sigma Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order