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

Preservative, Cytological

21 CFR 864.4010 / Pathology
FDA source (opens on fda.gov)

LEA is the FDA product code for Preservative, Cytological, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
LEA
Device name
Preservative, Cytological
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
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
4

Clearances, product code LEA

By decision year
4 clearances under product code LEA with a decision year between 1976 and 1987, 1976 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LEA by decision year
YearClearances
19762
19771
19871

Applicants with the most clearances

Product code LEA
Applicants holding the most 510(k) clearances under product code LEA
ApplicantClearances
Lerner Laboratories, Inc.2
Devetec, Inc.1
Surgipath Medical Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order