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

Kit, Anaerobic Identification

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

JSP is the FDA product code for Kit, Anaerobic Identification, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JSP
Device name
Kit, Anaerobic Identification
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
18
Ingested recalls
2

Clearances, product code JSP

By decision year
18 clearances under product code JSP with a decision year between 1977 and 1995, 1995 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JSP by decision year
YearClearances
19771
19802
19821
19832
19841
19851
19862
19882
19901
19911
19954

Applicants with the most clearances

Product code JSP
Applicants holding the most 510(k) clearances under product code JSP
ApplicantClearances
Microbiologics, Inc.3
Vitek Systems, Inc.3
Analytical Products, Inc.2
Innovative Diagnostic Systems, Inc.2
American Biomedical Products, Inc.1
American Micro Scan1
Austin Biological Laboratories1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Becton Dickinson Microbiology Systems1
Flow Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code