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

Fixative, Acid Containing

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

LDW is the FDA product code for Fixative, Acid Containing, 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 no recalls.

Classification record

Product code
LDW
Device name
Fixative, Acid Containing
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
0

Clearances, product code LDW

By decision year
4 clearances under product code LDW with a decision year between 1983 and 1988, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LDW by decision year
YearClearances
19831
19842
19881

Applicants with the most clearances

Product code LDW
Applicants holding the most 510(k) clearances under product code LDW
ApplicantClearances
E K Ind., Inc.2
Alpha-Tec Systems, Inc.1
American Micro Scan1

Companies listing this code with FDA

Companies whose registered establishments list this code