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

Plasma, Coagulase, Human, Horse And Rabbit

21 CFR 866.2160 / Microbiology
FDA source (opens on fda.gov)

JTL is the FDA product code for Plasma, Coagulase, Human, Horse And Rabbit, a class I device type, regulated under 21 CFR 866.2160. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JTL
Device name
Plasma, Coagulase, Human, Horse And Rabbit
Regulation
21 CFR 866.2160
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code JTL

By decision year
12 clearances under product code JTL with a decision year between 1979 and 1995, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JTL by decision year
YearClearances
19791
19812
19822
19832
19841
19861
19871
19881
19951

Applicants with the most clearances

Product code JTL
Applicants holding the most 510(k) clearances under product code JTL
ApplicantClearances
Analytical Products, Inc.2
Remel Co.2
American Scientific Products1
Difco Laboratories, Inc.1
Dutchland Laboratories, Inc.1
IMMY, Inc.1
Micro-Bio-Logics1
Otisville Biotech, Inc.1
Oxoid U.S.A., Inc.1
Quadroma, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code