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

Slides, Microscope

21 CFR 864.3010 / Pathology
FDA source (opens on fda.gov)

KEW is the FDA product code for Slides, Microscope, a class I device type, regulated under 21 CFR 864.3010. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KEW
Device name
Slides, Microscope
Regulation
21 CFR 864.3010
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
8
Ingested recalls
1

Clearances, product code KEW

By decision year
8 clearances under product code KEW with a decision year between 1976 and 1989, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KEW by decision year
YearClearances
19761
19801
19811
19821
19831
19881
19892

Applicants with the most clearances

Product code KEW
Applicants holding the most 510(k) clearances under product code KEW
ApplicantClearances
Stat Path2
Abco Dealers, Inc.1
Davstar California, Inc.1
Kallestad Laboratories, Inc.1
Miles Laboratories, Inc.1
Stan-Pak Ent.1
Technicon Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 98 companies shown, in name order