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

Second Antibody (Species Specific Anti-Animal Gamma Globulin)

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

KTS is the FDA product code for Second Antibody (Species Specific Anti-Animal Gamma Globulin), a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KTS
Device name
Second Antibody (Species Specific Anti-Animal Gamma Globulin)
Regulation
21 CFR 866.5510
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
4
Ingested recalls
0

Clearances, product code KTS

By decision year
4 clearances under product code KTS with a decision year between 1978 and 1981, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KTS by decision year
YearClearances
19781
19802
19811

Applicants with the most clearances

Product code KTS
Applicants holding the most 510(k) clearances under product code KTS
ApplicantClearances
Union Carbide Corp.2
Burroughs Wellcome Co.1
Pcl-Ria, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KTS.