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

Kit, Identification, Glucose Nonfermenter

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

JSW is the FDA product code for Kit, Identification, Glucose Nonfermenter, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JSW
Device name
Kit, Identification, Glucose Nonfermenter
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
6
Ingested recalls
0

Clearances, product code JSW

By decision year
6 clearances under product code JSW with a decision year between 1977 and 1992, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JSW by decision year
YearClearances
19772
19791
19871
19901
19921

Applicants with the most clearances

Product code JSW
Applicants holding the most 510(k) clearances under product code JSW
ApplicantClearances
Austin Biological Laboratories1
Biomerieux Vitek, Inc.1
Corning Medical & Scientific1
Innovative Diagnostic Systems, Inc.1
Micro-Media Systems, Inc.1
Micro-Palettes, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code