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

Kit, Mycoplasma Detection

21 CFR 864.2360 / Hematology
FDA source (opens on fda.gov)

KIW is the FDA product code for Kit, Mycoplasma Detection, a class I device type, regulated under 21 CFR 864.2360. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KIW
Device name
Kit, Mycoplasma Detection
Regulation
21 CFR 864.2360
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code KIW

By decision year
2 clearances under product code KIW with a decision year between 1985 and 1986, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KIW by decision year
YearClearances
19851
19861

Applicants with the most clearances

Product code KIW
Applicants holding the most 510(k) clearances under product code KIW
ApplicantClearances
Gibco Laboratories Life Technologies, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code