Product code KPB— Hematology

MYCOPLASMA ARGININI FITC (30-403-41)

Classification name: Media And Components, Mycoplasma Detection
Device class: Class 1
Regulation: 21 CFR 864.2360
Advisory panel: Hematology
Total cleared: 4
First cleared: 1977-11-17
Most recent: 1978-12-20

Market context for product code KPB

FDA has cleared 4 devices under product code KPB between 1977 and 1978, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19783 clearances
19771 clearance

Top applicants under product code KPB

Flow Laboratories, Inc.3 clearances
Bioassay Systems Research Corp.1 clearance

Recent clearances under product code KPB

K781874 — MYCOPLASMA ARGININI FITC (30-403-41)Flow Laboratories, Inc.·1978-12-20
K781875 — STAIN KIT FOR CELL CULTURES (30-100-00)Flow Laboratories, Inc.·1978-12-20
K781390 — MYCOPLASMA HYORHINIS (BTS-7)Flow Laboratories, Inc.·1978-09-01
K771867 — MYCOPLASMA DETECTION KITBioassay Systems Research Corp.·1977-11-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.