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

Fixative, Alcohol Containing

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

LDZ is the FDA product code for Fixative, Alcohol Containing, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LDZ
Device name
Fixative, Alcohol 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
8
Ingested recalls
0

Clearances, product code LDZ

By decision year
8 clearances under product code LDZ with a decision year between 1978 and 1988, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LDZ by decision year
YearClearances
19781
19831
19842
19861
19883

Applicants with the most clearances

Product code LDZ
Applicants holding the most 510(k) clearances under product code LDZ
ApplicantClearances
Alpha-Tec Systems, Inc.2
Accra Laboratories, Inc.1
American Micro Scan1
E K Ind., Inc.1
Mill-Rose Laboratory1
Surgipath Medical Industries, Inc.1
Zeus Scientific LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order