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

Anti-Dna Indirect Immunofluorescent Solid Phase

21 CFR 866.5100 / Immunology
FDA source (opens on fda.gov)

KTL is the FDA product code for Anti-Dna Indirect Immunofluorescent Solid Phase, a class II device type, regulated under 21 CFR 866.5100. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KTL
Device name
Anti-Dna Indirect Immunofluorescent Solid Phase
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
19
Ingested recalls
0

Clearances, product code KTL

By decision year
19 clearances under product code KTL with a decision year between 1979 and 2023, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KTL by decision year
YearClearances
19791
19832
19844
19862
19901
19931
19991
20011
20021
20182
20201
20232

Applicants with the most clearances

Product code KTL
Applicants holding the most 510(k) clearances under product code KTL
ApplicantClearances
Euroimmun US Inc.2
IMMUNO CONCEPTS, NA, Ltd.2
Intl. Diagnostic Technology2
Amersham Corp.1
Apple Diagnostic Products1
Breit Laboratories, Inc.1
Cappel Diagnostics, Inc.1
Immuno-Products Industries1
Inova Diagnostics, Inc.1
Rhigene, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code