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

Kit, Identification, Enterobacteriaceae

21 CFR 866.2660 / Microbiology
FDA source (opens on fda.gov)

JSS is the FDA product code for Kit, Identification, Enterobacteriaceae, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 49 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
JSS
Device name
Kit, Identification, Enterobacteriaceae
Regulation
21 CFR 866.2660
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
49
Ingested recalls
9

Clearances, product code JSS

By decision year
49 clearances under product code JSS with a decision year between 1976 and 2015, 1978 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JSS by decision year
YearClearances
19761
19771
19785
19794
19801
19814
19821
19835
19842
19853
19865
19881
19892
19922
19934
20081
20094
20101
20131
20151

Applicants with the most clearances

Product code JSS
Applicants holding the most 510(k) clearances under product code JSS
ApplicantClearances
Advandx, Inc.7
BD Becton Dickinson Vacutainer Systems Preanalytic3
Vitek Systems, Inc.3
Abbott Medical2
Austin Biological Laboratories2
Becton Dickinson Microbiology Systems2
Cnr Labs2
Dms Products, Inc.2
Flow Laboratories, Inc.2
Innovative Diagnostic Systems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code